The European Commission’s (EC’s) Directorate-General for Health and Food Safety recently published a survey of notified bodies. This was conducted between April and May 2023, eliciting responses from all 39 notified bodies designated under the Medical Devices Regulation (MDR) and 10 Notified bodies designated under the In Vitro Diagnostic Regulation (IVDR).

Imeka Solutions Inc. has received U.S. FDA 510(k) clearance for the Advanced Neuro Diagnostic Imaging system designed to provide neurologists and radiologists with vital reference information on cerebral white matter for better management of brain diseases such as Alzheimer’s. This comes on the heels of two new CPT 3 codes for quantitative brain MRI assessment which Imeka expects its clients will begin taking advantage of by January 2024.

Curvebeam AI Ltd. made its debut on the Australian Securities Exchange (ASX:CVB) after raising AU$25 million (US$16.175 million) in an initial public offering that will allow the company to market its flagship Hirise weight-bearing CT scan solution globally.

For many sports injuries, return-to-play decisions are pretty straightforward: pain and swelling have dissipated, or an X-ray confirms that a bone has healed. For concussion, it’s not so clear. Though symptoms may resolve after a few days, the brain could still be vulnerable. Now, Cupertino, Calif.-based based startup Mindrhythm Inc. has developed a headset to assess concussion recovery using biometric measures and help doctors safely return concussed individuals to play.

Neckepur SAS signed a licensing agreement with Assistance Publique-Hôpitaux de Paris (AP-HP) to develop an in vitro diagnostic technology to optimize the medical devices used in extracorporeal circulation. The agreement covers the rights to use a patent for a method of evaluating and optimizing the doses of drugs administered to patients admitted to the intensive care unit (ICU) who are undergoing treatment with devices such as hemofiltration, extracorporeal membrane oxygenation (ECMO), continuous hemodiafiltration, and adsorbent column circuits.

A recent bipartisan request for funding of a study on replacing U.S. drug patents with cash prizes is just one more symptom of a larger global malady that makes patents the scapegoat for bigger problems that have nothing to do with intellectual property (IP), David Kappos, board co-chair of the Council for Innovation Promotion (C4IP), told BioWorld.

Dermasensor Inc.’s elastic scattering spectroscopy device appears to have solved one of the more challenging issues in dermatology—early detection of skin cancers in individuals with darker skin tones. The device demonstrated very high sensitivity across all skin cancer types compared to histopathological exams with minimal variation between Fitzpatrick skin type groups in an analysis of the DERM-SUCCESS trial.

Developers of medical technology have many concerns about the U.S. Centers for Medicare & Medicaid Services’ (CMS) handling of coverage and reimbursement, but those controversies have typically revolved around process. A new report sponsored by industry steers a somewhat different tack, however, arguing that while there are issues of process, one key issue is that of funding, a problem that only Congress can remedy.