Pharma Marketing Network

SEPTEMBER 15, 2021

Maximizing Patient Safety and Sustaining Long Term Quality Through Enhanced Device Surveillance while navigating the EU Regulatory Landscape. In recent years the European Union has updated their requirements for Medical Device reporting following the FDA in the United States mainly with the EU Medical Device Regulation. REGISTER TODAY.

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Safety Medical Digital Media Marketing 52

Legacy MEDSearch

SEPTEMBER 27, 2022

Food and Drug Administration (FDA) 510(k) clearance for its CellFX System, expanding the indication for use to include the treatment of sebaceous hyperplasia in patients with Fitzpatrick skin types I-III. See Full Press Release at the Source: Pulse Biosciences Announces FDA 510(k) Clearance for the Treatment of Sebaceous Hyperplasia.

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FDA Food and Drug Administration Recruitment Medicine 98

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SEPTEMBER 26, 2023

Food and Drug Administration (FDA) has approved MRI conditional labeling for the Evoke ® System, the first and only precision, dose-control spinal cord stimulation (SCS) therapy powered by SmartLoop technology. Specific scan conditions and safety information are provided in the Evoke ® SCS System MRI Guidelines manual. Are you hiring?

Medical 52

Medical FDA Food and Drug Administration Safety 52

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JANUARY 13, 2023

implantation of the HIT Reverse Hip Replacement System (Reverse HRS), under an FDA approved Investigational Device Exemption (IDE). The IDE Study is being conducted to determine the safety and effectiveness of the HIT Reverse HRS in Primary Total Hip Arthroplasty (THA). Press Release by: Hip Innovation Technology. Are you hiring?

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FDA Safety Recruitment Patients 98

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DECEMBER 5, 2022

WISE Srl, a medical device company developing next-generation implantable electrodes for neuromonitoring, neuromodulation and brain-machine interfacing (BMI), announced the FDA clearance of its WISE Cortical Strip (WCS®) , a single use medical device intended to be used on the brain surface for Intra Operative Neurophysiological Monitoring (IONM).

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FDA Recruitment Leads Electronics 98

Legacy MEDSearch

OCTOBER 9, 2023

Food and Drug Administration’s (FDA) De Novo Classification Request process, a rigorous pre-market review pathway for medical devices with no existing predicate. FDA authorization was based, in part, on data from the #HOPE4LIVER Trials in 13 trial sites across the US and Europe. Are you hiring?

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FDA Food and Drug Administration Physicians Safety 52

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AUGUST 15, 2022

“The current version will enable reproducible analysis of patient data which will provide immediate value for our current and future biologics and drug delivery partners as they study volumetric infusion characteristics and longitudinal patient comparisons as part of their safety and pivotal trials. Press Release by: ClearPoint Neuro.

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FDA Recruitment Safety Patients 98

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APRIL 21, 2023

a privately held company that is developing innovative therapies in endovascular embolization, is pleased to announce it has received FDA Premarket Approval (PMA) of its Lava® Liquid Embolic System (Lava® LES) for treatment of peripheral arterial hemorrhage. Bay Area-based BlackSwan Vascular, Inc.,

FDA 52

FDA Safety Recruitment Prospecting 52

Legacy MEDSearch

SEPTEMBER 11, 2023

Dr. William Gormley, Chief Medical Officer of Zeta Surgical and Harvard Medical School Associate Professor, commented on the clearance: “The FDA’s market clearance of the Zeta Navigation system ushers in the next generation of innovation to neurosurgery. To learn more, visit: www.zetasurgical.com. Are you hiring?

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JUNE 30, 2023

Food and Drug Administration (“FDA”) for Cresilon Hemostatic Gel (“CHG ”). This marks Cresilon’s first FDA clearance for human use, validating its revolutionary hemostatic gel technology and the company’s global mission to transform wound care. ” said Cresilon CEO and Co-Founder Joe Landolina.

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FDA Food and Drug Administration Recruitment Medical 52

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AUGUST 17, 2022

FDA clearance for expanded indications for use for the Hummingbird® Tympanostomy Tube System (TTS) for office-based pediatric ear tube procedures. The company’s goal is to broaden the options available to ENTs and parents, focusing on the safety and comfort of the child, while reducing healthcare costs. Preceptis Medical, Inc.,

Medical 96

Medical FDA Recruitment Insurance 96

Legacy MEDSearch

JULY 11, 2023

Invictus Medical announced today that the culmination of their De Novo application to the FDA for its Neoasis ® incubator-based active noise control (ANC) device has resulted in a clearance-for-use declaration by the FDA. Invictus Medical is a privately held company. Are you hiring?

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Legacy MEDSearch

APRIL 11, 2023

Food and Drug Administration (FDA) granted marketing authorization of the MISHA Knee System, an implantable shock absorber (ISA) for the knee. I’m excited that the study met its superiority composite endpoint, which included effectiveness and safety components. Moximed is based in Fremont, California. Are you hiring?

Marketing 96

Marketing FDA Food and Drug Administration Specialization 96

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SEPTEMBER 5, 2023

a medical software innovator dedicated to enhancing clinical impact in ablation therapy, announced today that it has received 510(k) clearance from the USA Food and Drug Administration (FDA) for its VisAble.IO Techsomed Ltd., The BioTrace.IO Our clients include both blue-chip companies and innovative startups within the MedTech space.

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FEBRUARY 3, 2023

Food and Drug Administration (FDA) has granted the first marketing clearance for its SCINTIX biology-guided radiotherapy, a cutting-edge treatment applicable for early and late-stage cancers. The X1 also has a state-of-the-art anatomic modality previously cleared by the FDA for solid tumors located anywhere in the body.

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FDA Food and Drug Administration Recruitment Medical 97

Legacy MEDSearch

JUNE 19, 2023

The FDA approval is significant as it recognizes the safety and effectiveness of iTFlow® in analyzing blood flow through 4D Flow MRI data, with the potential to enhance diagnostic accuracy for patients with cardiovascular diseases and heart conditions. iTFlow® is an innovative software solution developed by Cardio Flow Design Inc.

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Legacy MEDSearch

MARCH 2, 2023

Food and Drug Administration (“FDA”) for the use of the Renuvion APR Handpiece “for the delivery of radiofrequency energy and/or helium plasma where coagulation/contraction of soft tissue is needed. For further information about the Company and its products, please refer to the Apyx Medical Corporation website at www.ApyxMedical.com.

Medical 52

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SEPTEMBER 18, 2023

Food and Drug Administration (FDA) has approved an investigational device exemption (IDE) supplement to permit the expansion of the study of the eShunt System in patients with Normal Pressure Hydrocephalus (NPH) to additional study participants and clinical sites. . CereVasc, Inc., Carl Heilman, M.D., and Adel Malek, M.D., Are you hiring?

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SEPTEMBER 29, 2023

The HYDR ogel A ugmentation F or I ntervertebral L umbar D iscs (HYDRAFIL-D) Study , is a multicenter, single-blinded, randomized, controlled trial to evaluate the safety and efficacy of the HYDRAFIL System for treatment of chronic low back pain due to degenerative disc disease. Vapotherm (NYSE:VAPO), and National Sleep Technologies.

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JULY 27, 2022

Rapid Medical , a leading developer of advanced neurovascular devices, announces FDA 510(k) clearance for TIGERTRIEVER 13 for large vessel occlusions at the 2022 Society of NeuroInterventional Surgery’s (SNIS) 19th Annual Meeting in Toronto. The ability to tailor each procedure can provide new safety levels for higher-risk thrombectomies.

Medical 52

Medical FDA Recruitment Physicians 52

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AUGUST 29, 2022

Food and Drug Administration (FDA) has approved an investigational device exemption (IDE) application to initiate a pilot trial of the eShunt ® System in patients who develop communicating hydrocephalus post aneurysmal subarachnoid hemorrhage (paSAH). . CereVasc, Inc., Press Release by: CereVasc. Are you hiring?

FDA 52

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AUGUST 25, 2022

Miracor Medical SA (Miracor Medical) has announced the approval of an Investigational Device Exemption (IDE) from the FDA, enabling the company to initiate a pivotal study with its Pressure-controlled intermittent Coronary Sinus Occlusion (PiCSO) technology. About Miracor Medical. Press Release by: Miracor Medical.

Medical 52

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AUGUST 23, 2023

Food and Drug Administration (FDA) Circulatory Systems Devices Panel of the Medical Devices Advisory Committee met to discuss the pre-market approval application (PMA) for the Paradise Ultrasound Renal Denervation (RDN) system, indicated to reduce blood pressure in patients with hypertension. Otsuka Medical Devices”) announce the U.S.

Medical 52

Medical Food and Drug Administration FDA Recruitment 52

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DECEMBER 6, 2022

With ActivSight, surgeons can access critical intraoperative visual data as augmented reality overlays, helping to increase surgical outcomes and patient safety. “As We believe ActivSight will be a game-changer in the operating room by revolutionizing surgical vision and, ultimately, improving surgical care and patient safety.

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Food and Drug Administration Safety Recruitment Medical 98

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MARCH 20, 2023

(NYSE American: ASXC), a medical device company that is digitizing the interface between the surgeon and the patient to pioneer a new era of Performance-Guided Surgery (PGS), announced that it has received 510(k) clearance from the FDA for an expanded indication to treat pediatric patients with the Senhance® System. Europe, and Japan.

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FDA Recruitment Patients Medical 52

Clarify Health

MAY 27, 2022

The US Food and Drug Administration (FDA) recently announced new draft guidance for life science companies on increasing diversity and inclusion in clinical trials to improve enrollments of underrepresented racial and ethnic populations. FDA Commissioner Robert M.

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FDA Food and Drug Administration Recruitment Transportation 52

Clarify Health

MAY 27, 2022

The US Food and Drug Administration (FDA) recently announced new draft guidance for life science companies on increasing diversity and inclusion in clinical trials to improve enrollments of underrepresented racial and ethnic populations. FDA Commissioner Robert M.

FDA 52

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MARCH 21, 2023

Food and Drug Administration (FDA). We look forward to working with the FDA on acceptance of our LUMISIGHT application for review and submitting the PMA for the Lumicell DVS in the second quarter.” Lumicell, Inc., Submission of the LUMISIGHT NDA is a significant step toward achieving this goal.

Food and Drug Administration 52

Food and Drug Administration FDA Recruitment Medical 52

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MARCH 17, 2023

The device was granted FDA Breakthrough Device designation and is currently under review by the FDA. “It There were no device-related safety issues reported in either study. The DermaSensor device’s FDA submission is pending review; it is not available for sale in the United States.

FDA 52

FDA Physicians Recruitment Medical 52

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DECEMBER 12, 2022

Under the new program, Highmark members prescribed by providers participating in the program will receive access to Nerivio ®, the first FDA-cleared, prescribed, digitally connected, drug-free wearable device for the acute treatment of episodic and chronic migraine in individuals aged 12 and older. Press Release by: Theranica.

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Side effects Insurance FDA Pharmacology 98

Clarivate

OCTOBER 19, 2023

Drug candidates have a high rate of failure, as only 10% of de-novo drugs put through clinical trials finally obtain market approval, with the highest rate of attrition occurring at phase I and II of clinical trials (assessing safety, tolerability, dosage, efficacy, and side effects). This process allows to impute/predict missing links.

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JUNE 28, 2023

4-7 Vbeam 595 nm PDL treatment during infancy can be done without general anesthesia, which offers a safety advantage over repeated treatments performed under general anesthesia, and it can maximize the likelihood of clearance with frequent but safe treatment sessions. ”, states board-certified cosmetic dermatologist, Roy G. .”,

Medical 52

Medical FDA Recruitment Side effects 52

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SEPTEMBER 1, 2022

eCential Robotics, a French growth MedTech company that designs and produces a system unifying 2D/3D imaging, surgical navigation and robotics, announced FDA 510(k) clearance of its 3D imaging, navigation and robotics guidance system, securing the penetration of its unified robotic platform in the United States. Securing the U.S.

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FDA Recruitment Marketing Medical 52

European Pharmaceutical Review

AUGUST 31, 2023

Overcoming challenges in patient safety, manufacturing and supply of radiopharmaceuticals As clinical trials progress and the first results are published, companies’ best candidates will emerge in the next five years. Hospital staff must also be protected from radiation while handling the agent.

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JULY 13, 2022

Food and Drug Administration (FDA) has granted Breakthrough Device Designation to the AccuCinch ® Ventricular Restoration System. The Breakthrough Designation is a valuable step in the pathway to FDA approval and we look forward to continuing to work closely with the agency in order to make the AccuCinch System available to these patients.”.

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Food and Drug Administration FDA Medical Recruitment 52

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NOVEMBER 29, 2022

“ IntelliMammo also provides Desert Imaging with comprehensive FDA Mammography Quality Standards Act (MQSA) EQUIP workflows and on-demand report generation that provides a framework for continuous quality improvement that aggregates and presents quality indicators across their sites, and supports ACR/MQSA compliance.

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pharmaphorum

JANUARY 5, 2023

Addiction treatment specialist Spero Health has expanded an agreement to use Pear Therapeutics’ prescription digital therapeutics (DTx) in its network of US clinics.

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Prescription Specialization FDA Networking 52