Baird Medical Investment Holdings Ltd.’s disposable microwave ablation (MWA) needle was approved by China’s National Medical Products Administration for treatment of benign thyroid nodules, which will help the company build a portfolio of products for thyroid diseases.
The U.S. Security and Exchange Commission’s final rule for disclosure of cybersecurity incidents would seem to weigh more heavily on device makers and their client hospitals than on other industries, particularly given that the draft rule required a four-day notification of any such events. The final rule retains that requirement to notify investors of any such breach within four days, although the SEC relented on the content of such disclosures to ease concerns about the potential for disclosures to amplify the cybersecurity threat.
Cardiologists have debated for some time whether obstructive sleep apnea (OSA) is a proven factor in a patient’s risk for heart disease, but the U.S. National Institutes of Health says newly published studies identify the specific mechanisms for this association. The studies offered data from more than 4,500 subjects and affirms the notion that OSA-driven hypoxia correlates well with the occurrence of a primary cardiovascular event, but the NIH says these findings need to be confirmed in another trial, hopefully one with enrollees whose OSA is deemed a high-risk version of the condition.
Teleflex Inc.’s agreement to acquire Palette Life Sciences AB for up to $650 million to boost its urology portfolio continues the company’s strategy of acquiring assets that are accretive to its growth rate. Palette has developed a number of urology products, key among them the Barrigel, a non-animal stabilized hyaluronic acid (NASHA) spacer that reduces radiation delivered to the rectum during prostate cancer radiation therapy. With radiation treatment trends increasing, the market for Barrigel is expected to grow.
During the week of July 24, 2023, the FDA published several notifications of potentially elevated risks associated with medical devices, including a recall of a delivery sheath for the Amplatzer device by Abbott Laboratories. The agency also announced that Abiomed Inc. will provide a correction for the instructions for use (IFUs) for the Impella because of an issue seen when implanting the left ventricular assist device in patients with transcatheter aortic valve replacement (TAVR) devices.
Arsenal Medical Inc. said its Neocast embolic material for neurovascular conditions was successfully used to treat its first patient. The patient was embolized as part of a first-in-human study to assess the safety and feasibility of Neocast for the embolization of brain tumors to more easily enable surgical removal.
Researchers from the University of Shanghai for Science and Technology have developed an electrotechnical patch, printed on a wearable substrate, capable of detecting dopamine and glucose levels in real-time. They published their work in Analytica.
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