Medical device companies face heightened cybersecurity burdens, antitrust enforcement and supplier risks, according to a new report out of Moody’s. The research firm’s previous quarterly report in February called attention to continued supply chain and labor problems for medtech. The report flagged legislative proposals for new rules and regulations on medical device developers and manufacturers, including new […]
FDA
FDA clears Fresenius’ next-gen portable automated peritoneal dialysis system
Fresenius Medical Care announced today it received FDA 510(k) clearance for its next-generation Versi PD cycler system. The company designed the portable automated peritoneal dialysis (APD) system (from Fresenius Medical Care North America) as a light, simple, quiet, portable and advanced platform for improving health equity by making home therapy a more feasible option for […]
Amazon Web Services is powering medtech innovation: Its chief medical officer explains
It doesn’t get any bigger than Amazon Web Services in the world of cloud computing. The cloud computing business at Seattle-based Amazon.com (Nasdaq: AMZN) is the largest player in the industry, with control of about a third of the market and a significant lead over cloud competitors Microsoft and Google. Dr. Taha Kass-Hout, the chief […]
FDA warns about non-invasive prenatal screening tests
The FDA issued a warning about the risk of false results, inappropriate use and inappropriate result interpretation with prenatal tests. Non-invasive prenatal screening (NIPS) tests, also known as cell-free DNA tests or non-invasive prenatal tests (NIPT) look for signs of genetic abnormalities in a fetus by testing a sample of blood from the pregnant person. […]
Philips has another round of serious ventilator recalls
Royal Philips’ (NYSE:PHG) ventilator problems continue as the company has issued further recalls for its respiratory devices. FDA earlier this week said it was designating more Philips recalls as Class I — the most serious kind. The recalls involve all models of the Philips Respironics V60 ventilator, the V60 Plus ventilator and the V680 ventilator […]
FDA approves IDE supplement for Virtual Incision’s miniaturized surgical robotics platform
Virtual Incision announced today that it received an FDA investigational device exemption (IDE) supplement for its MIRA platform. Lincoln, Nebraska-based Virtual Incision’s IDE supplement allows the company to complete the final stage of its clinical study for the MIRA (miniaturized in vivo robotic assistant) platform in bowel resection procedures. The company said in a news […]
FDA issues draft guidance for increasing racial and ethnic diversity in clinical trials
The FDA today issued a new draft guidance outlining plans for increased diversity in clinical trials in the U.S. Expanding upon previous guidances for improving clinical trial diversity, this latest draft guidance — “Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Subgroups in Clinical Trials” — recommends that sponsors of medical […]
FDA grants STeP designation for Pear Therapeutics’ neurobehavioral digital therapeutic
Pear Therapeutics (Nasdaq:PEAR) announced today that it received STeP designation from the FDA for its Pear-010 product candidate. Boston-based Pear Therapeutics designed its Pear-010 prescription digital therapeutic (PDT) candidate to provide a neurobehavioral intervention (virtual reality-delivered pain reduction) to patients 18 and older with acute postoperative and acute postprocedural pain. The company said in a […]
Merit Medical wins FDA clearance for wire-free breast localization system
Merit Medical Systems (Nasdaq:MMSI) announced today that it received FDA clearance for its Scout Bx delivery system. South Jordan, Utah-based Merit said in a news release that the technology represents the first wire-free breast localization solution that can be deployed at the time of stereotactic or MRI-guided biopsy. The company designed Scout Bx to be […]
FDA can’t explain record-low medical device recalls
Medical device product recalls were down 14.3% in the federal government’s fiscal year 2021, according to a recent Medical Design & Outsourcing analysis of recall data. The drop was the biggest since the FDA began publicly reporting the data in 2013, and came as the regulating agency put more emphasis on fighting the COVID-19 pandemic. We reached […]
Aidoc wins FDA clearance for brain aneurysm triage, notification platform
Aidoc announced today that it received its ninth FDA 510(k) clearance for triage and notification of brain aneurysms. New York-based Aidoc develops triaging and notification algorithms designed to flag and communicate certain conditions, allowing for increased efficiency in prioritizing incidental critical conditions through artificial intelligence (AI). The newly cleared algorithm adds the flagging and communication […]