EU health ministers have warned that developers of medical devices face trouble ahead in meeting deadlines for implementing the two new key regulations for medical devices (MDR) and in vitro diagnostics (IVDR). These were planned to enter into force in May 2021 and May 2022 respectively. EU executives and stakeholders have now all accepted that delays in complying with the regulations could result in issues achieving certification for medical devices, threatening shortages in the market.
Lepu Medical Technology (Beijing) Co. Ltd. received marketing approval from China’s NMPA for its peripheral cutting balloon to treat peripheral arterial disease.
Baxter International Inc. has scored FDA clearance for an infusion pump used to deliver small amounts of fluid at low rates, often in pediatric, neonatal and anesthesia care settings. The Novum Iq syringe infusion pump also features Dose Iq Safety Software, a web-based, customizable drug library that incorporates titration technology to reduce dosage errors during patient treatment.
China has issued a slew of measures to encourage domestic developers by constraining overseas-made medical devices from entering the market. “Policies to guide medical institutions to give priority to the purchase of domestic medical devices and consumables can help Chinese manufacturers to acquire market share. This also encourages domestic manufacturers to continue improving technology to narrow the technology gap with foreign firms,” said Cai Mingzi, analyst at Kaiyuan Securities Co. Ltd., in a note.
The U.S. FDA released a draft guidance for computer software assurance, a document that spells out the agency’s expectations for computer systems used to log a manufacturing site’s compliance and manufacturing activities.
Magnus Medical Inc. received FDA clearance for a neuromodulation platform to treat major depressive disorder (MDD) in adults for whom antidepressant medication has been ineffective.
The U.S. FDA has granted breakthrough device designation to Potrero Medical Inc. for its AKI Predict machine learning algorithm for the advanced prediction of acute kidney injury (AKI) associated with intra-abdominal hypertension (IAH) in intensive care patients recovering from cardiac surgery.
The toxicity associated with oncology therapies is the stuff of legend with clinicians and patients, and thus the U.S. FDA and manufacturers have been working to fine tune these dosing regimens. However, the FDA's Oncology Center of Excellence (OCE) includes a programmatic effort to optimize dosing regimens, which led to an editorial by FDA officials that calls on industry to consider whether the maximum tolerated dose paradigm is really the optimal approach to oncology drug development.
U.S. FDA commissioner Robert Califf resurrected a litany of complaints about medical product misinformation, including vaccinations for the COVID-19 pandemic, in a televised presentation heard by attendees at the Regulatory Affairs Professional Society (RAPS) annual conference here in Phoenix, where the daytime high temperatures are hovering at or near the century mark.
