BOSTON, Oct. 28, 2026 /PRNewswire/ — Empatica, a leader in digital biomarker development and clinical-grade wearable technology, today announced WellPD, an FDA-cleared and CE-marked wearable device and companion app for people with Parkinson’s to monitor their symptoms at home.
The clearance was secured 105 days after submission, with Deep Reasoning AI now planning to supply the platform in the US.
Pharaoh Neuro’s minimally invasive system for filtering cerebrospinal fluid has received a breakthrough designation from the FDA, with its design to clean out unwanted blood following certain internal brain bleeds
Abbott (NYSE: ABT) has secured an FDA approval for a minimally invasive system to plug new leaks in a replacement heart valve, without requiring the patient to undergo open surgery a second time.
MAPLE GROVE, Minn., Oct. 27, 2026 /PRNewswire/ — Vincora (NeoChord, Inc. d/b/a Vincora), a medical technology company developing transcatheter therapies for mitral valve repair, today announced that the U.S. Food and Drug Administration (FDA) has approved the Company’s Investigational Device Exemption (IDE) to initiate a U.S. Early Feasibility Study (EFS) of its investigational Transcatheter Chordal Repair System for the treatment of degenerative mitral valve regurgitation.
The regulatory clearance brings Coreline Soft’s total to 13 FDA 510(k) clearances and broadens its chest AI portfolio.
Elucid recently received FDA clearance for its AI-powered FFR-IQ software, which provides a noninvasive estimate of fractional flow reserve from coronary CT angiography.
After obtaining U.S. and European approvals this summer, Enable Injections has claimed its first regulatory green light in Japan for its enFuse wearable drug delivery technology.
Solventum (NYSE: SOLV) has acquired an FDA clearance for a new combination of two of its active wound care approaches, which the company said will help streamline the healing process.
The Teleflex (NYSE: TFX) Freesolve RMS (resorbable magnesium scaffold) has won FDA Breakthrough Device designation for percutaneous coronary intervention (PCI).