Legacy MEDSearch

JANUARY 13, 2023

Hip Innovation Technology , LLC (HIT), a medical device company developing innovative orthopaedic device solutions to advance the quality of life and quality of care for patients, is pleased to announce the first U.S. Safety will be assessed through the collection of device-related adverse events and patient quality of life metrics.

FDA 98

FDA Safety Recruitment Patients 98

Legacy MEDSearch

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. The approval provides patients implanted with the Evoke ® System the ability to undergo 1.5 head and extremity and 1.5T

Medical 52

Medical FDA Food and Drug Administration Safety 52

Legacy MEDSearch

NOVEMBER 7, 2022

a company committed to advancing surgical efficiency and safety, announced that they have received Safer Technologies Program (STeP) designation from the FDA for their surgical device StimSite. “Surgeons are constantly learning new techniques, either robotics or laparoscopic, and safety is always front and center.

Medical 95

Medical FDA Safety Recruitment 95

Legacy MEDSearch

AUGUST 15, 2022

This first-generation anatomical segment analysis tool emerged over 10 years ago from research aimed at detecting subtle volumetric and shape abnormalities in patients with mild traumatic brain injury. More importantly, it provides point-based correspondence longitudinally and across patients. About ClearPoint Neuro.

FDA 98

FDA Recruitment Safety Patients 98

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.

Safety 52

Safety Medical Digital Media Marketing 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. This system fills that void for both surgeons and patients.” I’m excited that the study met its superiority composite endpoint, which included effectiveness and safety components.

Marketing 96

Marketing FDA Food and Drug Administration Specialization 96

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.

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 Techsomed Ltd., VisAble.IO “We are excited to receive 510(k) clearance for our VisAble.IO The BioTrace.IO

FDA 52

FDA Food and Drug Administration Physicians Recruitment 52

Legacy MEDSearch

JULY 21, 2023

UroMems , a global company developing innovative, mechatronics technology to treat stress urinary incontinence (SUI), announced today that it has successfully completed the first-ever implant of the UroActive smart, automated artificial urinary sphincter (AUS) in a female patient. Food and Drug Administration (FDA) for UroActive. .

Food and Drug Administration 52

Food and Drug Administration Patients Safety 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. Itatani, MD, Ph.D., Cardio Flow Design Inc. Cardio Flow Design, Inc.

FDA 52

FDA Food and Drug Administration 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., About CereVasc, Inc. Press Release by: CereVasc.

FDA 52

FDA Food and Drug Administration Recruitment Physicians 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.

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. Recruitment in the European study is expected to end this summer.

Medical 52

Medical FDA Recruitment Pharmacology 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.

FDA 52

FDA Recruitment Patients Medical 52

European Pharmaceutical Review

AUGUST 31, 2023

Cancer patients critically depend on accurate diagnosis and disease treatment. By reaching cancer cells that have already spread throughout the body, a targeted radiopharmaceutical treatment offers an alternative for patients with advanced cancer when standard lines of treatment, such as chemotherapy, have failed.

Food and Drug Administration 82

Food and Drug Administration Manufacturing Safety Transportation 82

pharmaphorum

OCTOBER 26, 2022

And just as a family business thrives on its connection to the community, Chiesi is committed to connecting to the global patient community. We try to have a very long-term orientation because we believe that aligns our objectives very well with the objectives of society and the patients we serve, and it makes us a stable business.”.

Patients 89

Patients Pharma Consulting Transportation 89

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

MARCH 21, 2023

Food and Drug Administration (FDA). Lumicell is committed to revolutionizing the way breast cancer surgery is performed and bringing the benefits of the Lumicell Direct Visualization System to breast cancer patients,” said Kevin Hershberger, president and chief executive officer of Lumicell. Lumicell, Inc.,

Food and Drug Administration 52

Food and Drug Administration FDA Recruitment Medical 52

PM360

SEPTEMBER 15, 2022

The term “patient centricity” has been around for over a decade, and since its first utterance the buzzword has been praised, dissected, criticized, and everything in between. The concept has always been worthwhile, but people within and outside of the industry have wondered whether the industry was truly becoming more patient centric?

Patients 98

Patients Healthcare Healthcare Marketing 98

Legacy MEDSearch

JUNE 28, 2023

2 The incidence of infantile hemangiomas (IHs) in neonatal patients (under 28 days of age) varies, with a reported rate ranging from 1.1 2 The incidence of infantile hemangiomas (IHs) in neonatal patients (under 28 days of age) varies, with a reported rate ranging from 1.1 ”, states board-certified cosmetic dermatologist, Roy G.

Medical 52

Medical FDA Recruitment Side effects 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

JULY 13, 2022

Food and Drug Administration (FDA) has granted Breakthrough Device Designation to the AccuCinch ® Ventricular Restoration System. This program is designed to ensure patients and healthcare providers have more timely access to these medical devices. Ancora Heart , Inc., An estimated 6.5 million U.S. An estimated 6.5 million U.S.

Food and Drug Administration 52

Food and Drug Administration FDA Medical Recruitment 52

Legacy MEDSearch

MARCH 17, 2023

Prompt referral from a PCP to a dermatologist can help minimize patient mortality, morbidity and result in the saving of health care dollars.” 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.

FDA 52

FDA Physicians Recruitment Medical 52

Legacy MEDSearch

MARCH 24, 2023

a company developing a completely transcatheter device-based therapy to address heart failure (HF), announced that patients treated with the investigational AccuCinch ® Ventricular Restoration System demonstrated improvement in HF patient outcomes and beneficial changes in the structure of the heart. Ancora Heart, Inc.,

Patients 52

Patients Recruitment Medical Medicine 52

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.

Networking 59

Networking Consulting Safety Side effects 59

Legacy MEDSearch

NOVEMBER 29, 2022

generated image quality assessments while the patient is still in the exam room, and supports reduced technical recalls and improved mammography quality. Densitas ® is a global leader in artificial intelligence solutions for breast cancer screening, focused on quality, safety, efficiency, and precision breast health.

Recruitment 98

Recruitment FDA Engineering Management 98

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. We believe having access to patient-reported data via Pear’s clinician dashboard gives us better insight into patient behaviours.”.

Prescription 52

Prescription Specialization FDA Networking 52

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

European Pharmaceutical Review

SEPTEMBER 2, 2022

To ensure the safety of medicines post-regulatory approval, a risk management plan (RMP) is established. As does the US Food and Drug Administration (FDA): REMS Assessment: Planning and Reporting Guidance for Industry Draft Guidance. What are risk minimisation methods?

Food and Drug Administration 78

Food and Drug Administration Medicine Safety Food 78

European Pharmaceutical Review

MARCH 12, 2024

Regulatory bodies such as the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) place great importance on data integrity in the pharmaceutical/life science industry. Blockchain technology creates a decentralised and unalterable ledger that records all transactions across a network of computers.

Government 91

Government Pharma Ethics Training 91

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. As for clinical efficacy, 74.1%

Side effects 52

Side effects Recruitment Networking Management 52

Legacy MEDSearch

JUNE 27, 2022

Centerline Biomedical’s system improves visualization and guidance in endovascular procedures while reducing dependence on radiation and contrast agents with the goal of improving patient outcomes, as well as overall efficiency for clinicians. IOPS® is FDA 510(k) cleared and currently launching in the US at select sites.

Recruitment 52

Recruitment Healthcare Healthcare Safety 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

JULY 10, 2023

“This submission is another milestone in KORU Medical’s mission to make subcutaneous therapy radically simpler and easier for patients. . “This submission is another milestone in KORU Medical’s mission to make subcutaneous therapy radically simpler and easier for patients.

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 94

Medicine Food and Drug Administration Pharmaceutical products Pharmaceutical 94