The U.S. Department of Health and Human Services (HHS) is turning to venture capital to speed the development of medical devices to stave off or fight public health emergencies. HHS’s Biomedical Advanced Research and Development Authority (BARDA) plans to provide the nonprofit Global Health Investment Corporation (GHIC) with a minimum of $50 million over five years, with […]
Italian sterilization plants falsified records for years, FDA says
An Italian medtech sterilization company falsified records of various FDA-regulated products since 2016, the agency said today. The company, Steril Milano, falsified graphs and parameters of sterilization certificates for devices processed at its Reggiolo and Monza ethylene oxide (EtO) plants, the FDA said. Steril Milano on March 9, 2021, announced the temporary closure of the Monza […]
FDA seeks more money, authority in budget request
The FDA wants more money from Congress for the coming fiscal year — and more power, too. Out of its $6.5 billion total budget, the agency is asking $676.55 million for its medical device program. That includes $571 million for the Center for Devices & Radiological Health (CDRH) and $105.4 million for the Office of Regulatory […]
Edwards’ low-BP prediction software gains FDA clearance
Edwards Lifesciences (NYSE:EW) has announced that its Acumen hypotension prediction index (HPI) software has received FDA 510(k) clearance. Using data obtained from the Acumen IQ finger cuff, the software uses machine learning to alert clinicians of the likelihood a patient is trending toward hypotension, or low blood pressure. Until now, Acumen HPI software has only […]
Medtronic implant found better at predicting AFib than external device
A Medtronic implant was three times better than an external monitor at detecting new atrial fibrillation in stroke patients, a new study says. The Post-Embolic Rhythm Detection With Implantable Versus External Monitoring (PER DIEM) study pitted Medtronic’s Reveal Linq implantable device, which monitors for AFib over 12 months, against the Spiderflash-T external device made by […]
FDA shifts gears as mask shortages ease
The FDA wants healthcare providers to move away from using certain imported disposable masks, such as KN95s. The recommendation to ease off using non-NIOSH-approved masks comes less than two months after the agency said providers could transition away from reusing decontaminated masks. Get the full story on our sister site, Medical Design & Outsourcing.
MedTech Europe warns on ongoing regulatory issues
MedTech Europe welcomed the first wave of new E.U. medical device regulations this week, but said there’s work that’s yet to be done. The trade group noted that EU MDR — the new regulatory regime for medical devices — strengthens the system of notified bodies, or companies that conduct audits on each device whose manufacturer […]
FDA issues draft guidance on medical device postmarket issues
The FDA today released a pair of draft guidances on postmarket requirements for certain medical devices. The first guidance was written to help manufacturers of certain Class II (moderate-risk) and Class III (high-risk) devices for which the agency has issued a postmarket surveillance (522) order. The FDA may issue a 522 order at any time […]
Lucid Diagnostics gains CE mark for esophageal device
Lucid Diagnostics has received the CE mark for its EsoCheck esophageal cell collection device, its parent company announced today. EsoCheck is an FDA-cleared, swallowable balloon capsule catheter that enables a clinician to sample surface cells from the esophagus in a less than five-minute, non-invasive office procedure. Lucid touts EsoCheck as the only such device capable of […]
EU MDR finally goes into effect
The E.U.’s Medical Device Regulation (MDR) takes effect tomorrow, changing the process to gain entry to the continental market. EU MDR replaces the EU Medical Device Directive (MDD) with more stringent requirements on the companies that perform the audits for each device, also known as notified bodies. The change affects not only devices that are […]
PAVmed wins CE mark for carpal tunnel device
PAVmed (NSDQ: PAVM) today announced that it has received the CE mark for its CarpX minimally invasive carpal tunnel device. EU-based Notified Body TÜV Rhineland LGA Products GMBH issued CE certificate, effective May 24, 2021, the company noted. CarpX may now be marketed in CE Mark European countries, which include the European Economic Area (the EU, […]