#fda-clearance

#fda-clearance

Lund-based MedVasc has announced they have successfully completed production and testing activities in accordance with its plan. In parallel, the company closed a new financing round at the end of 2025, raising € 2.2 million (SEK 24 million) from existing shareholders. With the financing secured, MedVasc is well positioned to accelerate the remaining key activities required for FDA clearance of Solutio™ for the U.S. market. Preparations are progressing according to plan, and market approval is expected during autumn 2026.

Natural Cycles, the company behind a controversial FDA-cleared birth control app, is replacing its thermometer with a wristband that measures skin temperature, heart rate, and movement during sleep. The newly-launched wristband costs $129.99 and syncs with the Natural Cycles app, which uses an algorithm to determine a person's "daily fertility status." Users can already track their fertility by pairing an Apple Watch or Oura Ring with Natural Cycles, but the wristband could be an option for users who don't have either of these devices handy.

Dining out at new restaurants can be a fun way to try different cuisines and get together with friends. For people with allergies, though, eating food they haven't prepared themselves in a new place can pose a serious threat. Cross-contamination can happen anywhere, and food-related anaphylaxis sends patients to the emergency room every six minutes, according to the Journal for Allergy and Clinical Immunology.

Now that it's successfully completed a pilot period, the company is bringing a 30-minute, lab-accurate PCR test for three common sexually transmitted infections to women at home. From a self-collected vaginal swab, the $149.99 test can diagnose chlamydia, gonorrhea, and trichomoniasis-three common infections that can all easily be treated with antibiotics. It also connects patients who test positive with a healthcare provider via United Healthcare's OptumNow telehealth service.

Apple just announced a bunch of new health tracking features alongside its new smartwatch lineup - but you might not need to upgrade your device to get access to them. With the launch of watchOS 26 next week, Apple will bring hypertension notifications, live translation, and the new wrist flick gesture to the Watch Series 9 and newer, along with the last-gen Watch Ultra 2.