To open up access to mental health services during the Coivd-19 pandemic, the FDA is allowing digital health companies to release products that have not yet been approved. Under this temporary guidance, Pear Therapeutics launched limited distribution of a digital therapeutic for people with schizophrenia.
Nuvo Group received 510k clearance from the Food and Drug Administration for its wearable sensor band, which can monitor fetal and maternal heart rate data.
FDA is modernizing its 510(k) program and one change it is mulling is placing a limit on how old a predicate device is when manufacturers develop a new product showing substantial equivalence.
The IEC 60601 standard is one part of putting together a technical file or a 510(k) submission. It’s about more than electrical safety — it covers mechanical safety, labeling, and risk management.
Cardiac mapping has been an important tool to make ablations safe and effective, but it has required catheterization, unlike Medtronic's new product.
TytoCare will bundle the stethoscope with other FDA-listed medical devices for healthcare professionals or even consumers to initiate telehealth exams.
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
Filing 510(k)s isn't always an easy process. Here are some tips to avoid setbacks.
MedShape, Inc., an Atlanta, Ga.-based medical device company, announced it closed an $11 million funding round that will go toward a full-market launch of the Eclipse Soft Tissue Anchor. The product, made from proprietary thermoplastic, is a shape-memory, soft-tissue repair device that allows surgeons to attach tendons, ligaments or soft tissue to bone. Its shape both […]
No more catheter, no more cuff for monitoring patient vital signs? Sotera Wireless announced the FDA has given 510(k) clearance to its continuous non-invasive blood pressure (cNIBP) technology, a new feature of its ViSi Mobile patient monitoring system. “For the first time clinicians can continuously monitor all patient vital signs, including beat-to-beat blood pressure, without the […]
Chattanooga, Tenn.-based Advanced Catheter Therapies received FDA 510(k) clearance for its Occlusion Perfusion Catheter, a multi-lumen balloon catheter on Tuesday. The medical device technology can measure pressure inside the treatment chamber, as well as “its inflow and outflow ports for chamber evacuation, filling and flushing,” according to a press release. The catheter is designed to […]
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.
The standard of care for port site closures in laparoscopic surgery may be changing. Irish medical device startup neoSurgical‘s first commercialized product, neoClose, officially launched this week in the U.S. Today, the Society of Laparoendoscopic Surgeons named the device one of the 2013 Innovations of the Year at the SLS Minimally Invasive Surgery Week Annual Meeting. […]
Zimmer Holdings, Inc. (ZMH) may have gone down swinging in its most recent courtroom drama with Stryker, but the orthopedics giant may be set to prop itself back up. The FDA gave the Warsaw, Ind.-based company 510(k) clearance for the Patient Specific Instrument Shoulder system. The clearance is to work hand-in-hand with another Zimmer device–the […]
Boston Scientific (BSX) announced it has received U.S. Food and Drug Administration approval for its IntellaTip MiFi XP catheter and 501(k) clearance for its Zurpaz 8.5F steerable sheath, growing its EP mapping/ablation technology portfolio. This makes it the third major player–following both St. Jude Medical, which acquired Endosense, and GE, which invested in Acutus Medical–to […]
Reflectance Medical, Inc. has received FDA 510(k) clearance for a noninvasive device that could help clinicians determine whether a patient is in shock or pre-shock or has tissue acidosis in real time at the point of injury or care. It’s the only noninvasive pHm monitoring device, and aims to save providers money by reducing ICU […]
A Minneapolis law firm has filed a joint petition on behalf of a group of pre-revenue, small and midsized device companies, venture capitalists and inventing physicians that aims to prevent the U.S. Food and Drug Administration from unlawfully changing how the 510(k) program operates. The Minnesota Medical Device Alliance (MMDA) filed the citizen petition and […]
