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AVNA Opens New Mfg Plant in Costa Rica's Evolution Free Zone

3 days ago | mpo-mag.com | Sam Brusco

AVNA, a manufacturer of medical device components and subassemblies, has relocated and expanded its Costa Rice operations to the new Evolution Free Zone, in Grecia Costa Rica. The investment totaled $5.5 million and represented a 116% increase of production capacity. The opening positions the company as the anchor tenant of the business part and reinforced its commitment to growth in Costa Rica.
Resmed Taps Illumina Exec for Chief Investor Relations Officer

3 days ago | mpo-mag.com | Sam Brusco

Resmed has appointed Salli Schwartz as its new chief investor relations officer, effective April 21. Schwartz will lead the company’s global investor relations and report to chairman and CEO Mick Farrell. Schwartz touts over two decades of experience in finance roles at healthtech and financial services organizations. She joins Resmed from Illumina, where she was head of investor relations.
Orchestra BioMed Earns Breakthrough Status for AVIM Hypertension Therapy

3 days ago | mpo-mag.com | Sam Brusco

Orchestra BioMed has been granted Breakthrough Device Designation (BDD) from the U.S. Food and Drug Administration (FDA) for its atrioventricular interval modulation (AVIM) therapy.
Biolinq Secures $100M Series C Funding for Biosensor Patch

3 days ago | mpo-mag.com | Sam Brusco

Biolinq, a company pioneering precision, multi-analyte sensors to improve metabolic health, has received a $100 million Series C financing led by Alpha Wave Ventures. Participation also occurred from existing investors RiverVest Venture Partners, AXA IM Alts, LifeSci Venture Partners, M Ventures, Hikma Ventures, Aphelion Capital, Taisho Pharmaceutical and Features Capital.
BD Releases HemoSphere Alta AI-Powered Hemodynamic Monitoring Tech

3 days ago | mpo-mag.com | Sam Brusco

BD (Becton, Dickinson and Company) launched HemoSphere Alta, an advanced hemodynamic monitoring platform with predictive artificial intelligence (AI)-based algorithms to help proactively address blood pressure instability and optimize blood flow. HemoSphere Alta is the first product launch from the Advanced Patient Monitoring business since BD’s acquisition from Edwards.
Ypsomed to Sell Diabetes Care Biz to TecMed for $517M

3 days ago | mpo-mag.com | Sam Brusco

Ypsomed has begun a deal to sell its diabetes care business for up to CHF 420 million (about $517 million) to TecMed, a Swiss company controlled by Willy Michel. The company is selling Ypsomed Diabetes Care AG, including subsidiaries, patch pump development activities, and related rights. Ypsomed said it’s making the sale to focus on strengthening its market position for subcutaneous self-injection solutions for pharma and biotech companies.
Paragonix Celebrates 100th Kidney Transplant Case with KidneyVault

4 days ago | mpo-mag.com | Sam Brusco

Paragonix Technologies has successfully completed its hundredth cases using the U.S. Food and Drug Administration (FDA)-cleared KidneyVault portable renal perfusion system. The milestone was achieved with support of Tennessee Donor Services (TDS), an Organ Procurement Organization (OPO) that serves over six million people across Tennessee and Virginia. KidneyVault is the first hypothermic machine perfusion device designed to maximize mobility.
Medtronic Wins FDA Nod for Simplera Sync CGM with MiniMed 780G Insulin Pump

4 days ago | mpo-mag.com | Sam Brusco

Medtronic has earned U.S. Food and Drug Administration (FDA) approval for its Simplera Sync continuous glucose monitor (CGM) for use with the MiniMed 780G insulin delivery system. Simplera Sync is a disposable, all-in-one sensor that requires no fingersticks with SmartGuard or overtape. It also has a simple, two-step insertion process, according to the company. MiniMed 780G’s adaptive algorithm automatically anticipates, adjusts, and corrects glucose levels every five minutes.
FDA OKs Solo Pace's Temporary Pacing During TAVR

1 week ago | mpo-mag.com | Sam Brusco

Emerging medtech company Solo Pace has achieved U.S. Food and Drug Administration (FDA) clearance and first-in-human use of its SoloPace control system for temporary pacing in transcatheter aortic valve replacement (TAVR) surgeries. SoloPace was designed to improve TAVR temporary pacing efficiency and reduce risks. The first cases were performed this month at Scripps Clinic by Chief of Cardiology, Paul Teirstein, MD and Curtiss Stinis, MD.
Adagio Wins FDA Breakthrough Nod for vCLAS Cryoablation

1 week ago | mpo-mag.com | Sam Brusco

Adagio Medical Holdings, a company focused on catheter ablation tech to treat cardiac arrhythmias, has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for its vCLAS cryoablation system to treat drug-refractory, recurrent, sustained monomorphic ventricular tachycardia (VT) in patients with ischemic or non-ischemic structural heart disease. vCLAS is currently amid the FULCRUM-VT investigational device exemption (IDE) study.