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?

FDA 52

FDA Food and Drug Administration Physicians Safety 52

Legacy MEDSearch

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 solution is not yet approved for sale or distribution in the USA and is limited by USA law to investigational use.

FDA 52

FDA Food and Drug Administration Physicians Recruitment 52

Legacy MEDSearch

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.

FDA 52

FDA Food and Drug Administration Recruitment Medical 52

Legacy MEDSearch

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?

Food and Drug Administration 52

Food and Drug Administration FDA Patients Recruitment 52

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?

FDA 52

FDA Medical Recruitment Specialization 52

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

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

Medical FDA Food and Drug Administration Recruitment 52

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.

FDA 52

FDA Food and Drug Administration Recruitment Physicians 52

Legacy MEDSearch

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.

FDA 52

FDA Recruitment Patients Medical 52

Legacy MEDSearch

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

Legacy MEDSearch

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

FDA Food and Drug Administration Recruitment Physicians 52

Legacy MEDSearch

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 is currently CE Marked and is available for sale in Australia. For more information, please visit booth #2221.

FDA 52

FDA Physicians Recruitment Medical 52

Legacy MEDSearch

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.

Food and Drug Administration 98

Food and Drug Administration Safety Recruitment Medical 98

Legacy MEDSearch

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

Legacy MEDSearch

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

Medical FDA Recruitment Pharmacology 52

Legacy MEDSearch

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.

Side effects 98

Side effects Insurance FDA Pharmacology 98

Legacy MEDSearch

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

Legacy MEDSearch

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

Legacy MEDSearch

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.”.

Food and Drug Administration 52

Food and Drug Administration FDA Medical Recruitment 52

Legacy MEDSearch

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.

Recruitment 98

Recruitment FDA Engineering Management 98

Legacy MEDSearch

AUGUST 8, 2022

MicroPort Navibot has received 510(K) clearance from the Food and Drug Administration (FDA) in the United States for the SkyWalker System, the company’s first robot-assisted platform for orthopedic applications. The SkyWalker System has the technical advantages of precise operation and efficient coordination, while prioritizing safety.

Food and Drug Administration 98

Food and Drug Administration Recruitment Medical Food 98

Pharma Marketing Network

AUGUST 9, 2023

It’s crucial for marketing teams to stay informed about the latest guidelines, policies, and updates from regulatory bodies such as the Food and Drug Administration (FDA) in the United States or the European Medicines Agency (EMA) in the European Union.

Marketing 52

Marketing Pharma Food and Drug Administration Media 52

Legacy MEDSearch

JUNE 27, 2022

This funding will help propel the company into new surgical applications, accelerate its commercial sales and add to its growing clinical evidence repository. IOPS® is FDA 510(k) cleared and currently launching in the US at select sites. Expansion to Europe and other key markets will occur in 2023.

Recruitment 52

Recruitment Healthcare Healthcare Safety 52

PM360

SEPTEMBER 21, 2023

Generic Drug Launches This year could see up to 50 generic drug approvals on brand pharmaceuticals worth more than $20 billion in sales, Casberg noted. billion in sales. The product had sales of roughly $800 million per year. The drug generated $2 billion in sales last year. “We’re

Management 105

Management Manufacturing Sales Competition 105

Legacy MEDSearch

JULY 21, 2023

This first-in-female procedure was approved by the National Agency for the Safety of Medicines and Health Products (or ANSM, the French equivalent to the U.S. Food and Drug Administration (FDA) for UroActive. UroActive has not received marketing authorization from the FDA and is not available for sale in the United States or in the EU.

Food and Drug Administration 52

Food and Drug Administration Patients Safety Recruitment 52

Pharma Marketing Network

AUGUST 9, 2023

It’s crucial for marketing teams to stay informed about the latest guidelines, policies, and updates from regulatory bodies such as the Food and Drug Administration (FDA) in the United States or the European Medicines Agency (EMA) in the European Union.

Marketing 40

Marketing Pharma Food and Drug Administration Media 40

Legacy MEDSearch

OCTOBER 25, 2023

Theranica , a neuromodulation therapeutics company, announced the publication of a comprehensive clinical study in Advances in Therapy examining the long-term utilization, clinical efficacy, and safety of Nerivio ® , a Remote Electrical Neuromodulation (REN) device for the treatment of migraine.

Side effects 52

Side effects Recruitment Networking Management 52

Legacy MEDSearch

JULY 10, 2023

” The FDA approved the 50 mL Hizentra prefilled syringe in April 2023. The FREEDOM Infusion System currently includes the FREEDOM60 ® and FreedomEdge ® Syringe Infusion Drivers, Precision Flow Rate Tubing and HIgH-Flo Subcutaneous Safety Needle Sets. For more information, please visit www.korumedical.com.

Medical 40

Medical Food and Drug Administration Recruitment Manufacturing 40

European Pharmaceutical Review

AUGUST 23, 2022

FAKE MEDICINES are not a new problem, and pose a tremendous threat to patient safety and public health in society regardless of a country’s economic status. The US Food and Drug Administration (FDA) further estimates that 97 percent of online pharmacies are operating illegally. This allows for a cyber?

Medicine 92

Medicine Food and Drug Administration Pharmaceutical products Pharmaceutical 92

Legacy MEDSearch

JUNE 16, 2023

The prospective, randomized clinical trial is designed to evaluate the safety and effectiveness of the pro disc C Vivo and pro disc C SK system by comparing it with an approved TDR product as a control for 2-level indications, making it the first and only of its kind with two investigational devices and a TDR control.

Food and Drug Administration 52

Food and Drug Administration Recruitment Safety Medical 52

Legacy MEDSearch

JULY 11, 2022

based Food and Drug Administration (FDA) study to evaluate improvements in visual acuity and safety of the device in people living with late-stage AMD. We intend to work closely with the FDA to determine a timely pathway to bring the SING IMT to market in the United States.”. There is no cure for late-stage AMD.

Food and Drug Administration 52

Food and Drug Administration Recruitment FDA Patients 52

Legacy MEDSearch

MARCH 24, 2023

The safety outcome measure included freedom from major adverse events (MAEs) related to the device implantation or femoral artery access through 12 months post-procedure. 1 The pivotal CORCINCH-HF Study, a randomized, controlled trial, is currently underway to assess the clinical safety and efficacy of the AccuCinch System in HFrEF patients.

Patients 52

Patients Recruitment Medical Medicine 52

Legacy MEDSearch

MAY 23, 2022

2015) designs devices to set new operating-room standards for efficiency and patient safety. Lazurite’s ArthroFree System is the first wireless surgical camera system to receive FDA market clearance for arthroscopy and general endoscopy. The Cleveland-based company (est.

Food and Drug Administration 52

Food and Drug Administration Medicine Recruitment Physicians 52

Legacy MEDSearch

MARCH 13, 2023

Food and Drug Administration (FDA) has granted an Investigational Device Exemption (IDE) to advance the company’s PATCH Clinical Study, a multi-center, single-arm, pivotal study evaluating the safety and effectiveness of the Vivasure PerQseal ® Closure Device System. The post Vivasure Medical Announces FDA IDE Approval to Initiate U.S.

Medical 98

Medical FDA Food and Drug Administration Recruitment 98

Legacy MEDSearch

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).

FDA 98

FDA Recruitment Leads Medical 98

Legacy MEDSearch

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.

FDA 97

FDA Food and Drug Administration Recruitment Medical 97

Legacy MEDSearch

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