MedTech News
.................... by Andrew Celentano

Alleviant Medical wins FDA IDE, breakthrough nods for no-implant heart failure treatment
Alleviant Medical announced today that it received FDA investigational device exemption (IDE) and breakthrough device designation for its atrial shunt.

AccurKardia wins FDA breakthrough nod for hyperkalemia detection software
AccurKardia announced today that it received FDA breakthrough device designation for its ECG-based, AI-powered hyperkalemia detection software.

CeQur raises $120M to support insulin delivery tech
Insulin delivery technology developer CeQur today announced a significant funding round to support its commercialization efforts.

Francis Medical raises $80M Series C for water vapor ablation tech
Francis Medical announced today that it completed an oversubscribed $80 million Series C equity financing.

Fire1 raises $120M for breakthrough heart failure management tech
Fire1 announced today that it completed a $120 million financing round to accelerate the advancement of its heart failure management system.

Introducing isaac by PreEvnt™ – Non-Invasive Blood Glucose Alert Device at the CES Digital Health Exhibit
OXNARD, Calif., Jan. 6, 2025 /PRNewswire/ — PreEvnt, a subsidiary of SCOSCHE Industries, a leading innovator of award-winning consumer technology will proudly unveil isaac* by PreEvnt at the Digital Health Exhibit at CES.

Medtronic gets CE mark for Harmony transcatheter pulmonary valve
Medtronic (NYSE: MDT)+
today announced CE mark approval for its Harmony transcatheter pulmonary valve (TPV) system
PieX AI launches AI-powered pendant sensor device for mental health
PieX AI announced today that it launched a pendant featuring on-device AI for managing mental health through sensing technology.