The FDA’s Center for Devices and Radiological Health posted two important guidances just in the first week of the new year. The agency seems determined to sustain that pace with a new draft guidance for cuffless blood pressure monitors, apparently in response to sales of unauthorized over-the-counter devices for this indication.
Once it was considered to be more or less a passive energy-storing device that could double as a cushion. But increasingly, fat is conceptualized as an endocrine organ as much as a tissue type. Now, separate research groups have reported new insights into the functional roles of different fats based on their anatomical location and functional characteristics.
An international team of researchers has successfully used Onward Medical N.V.’s ARC-IM therapy to develop a neurostimulation system that improves blood pressure stability in patients with spinal cord injuries. According to data from two studies published in Nature and Nature Medicine, the implanted system also led to durable reduction of hypotensive symptoms, resulting in an improvement in the quality of life of patients.
Onward Medical NV secured U.S. FDA investigational device exemption (IDE) approval for a pivotal study to assess the safety and efficacy of its implantable spinal stimulation technology, the ARC-IM system. The Empower study BP study will focus on addressing blood pressure instability in patients with spinal cord injury (SCI).
Deepqure Inc. gained clinical trial clearance from South Korea’s Ministry of Food and Drug Safety to test its Hyperqure renal denervation system for the treatment of atrial fibrillation.
Aktiia SA raised $42 million in an oversubscribed series B funding round and rebranded to Hilo. The funds will be used for product innovation, expansion into new markets and to build out its blood pressure monitoring platform to support enterprise use cases.
Sky Labs Inc. CEO and founder Jack Byunghwan Lee reported on plans to greatly expand the market for the company’s blood pressure monitor ring, including seeking regulatory approvals for the CART BP products in the U.S., Europe and Japan.
George Medicines, a new spinout from Australia’s George Institute for Global Health, could offer patients better control of their blood pressure as well as fewer side effects thanks to an ultra-low-dose triple combination.
George Medicines, a new spinout from Australia’s George Institute for Global Health, could offer patients better control of their blood pressure as well as fewer side effects thanks to an ultra-low-dose triple combination. A polypill that combines multiple medicines into a single tablet, GMRx2 was developed out of a 20-year research program at The George Institute for Global Health. The single pill is a combination of three best-in-class medicines: telmisartan, amlodipine and indapamide.
A new position paper from the International Society of Hypertension pinpoints the benefits and drawbacks of novel blood pressure management technology, including the latest cuff-based and cuffless and wearable devices like BP-measuring watches and rings.
