Tandem Diabetes Care’s new CEO inherits a growing $1bn business. Can she deliver profitability?
Tandem Diabetes Care names Jeannette Bankes CEO amid 14% sales growth. Examine her strategy, $10 million equity award and profitability outlook.
Pharma & Biotech
Features & Analysis
A new TAVR protection device catches debris beyond the brain. Can Emboline turn engineering superiority into clinical value?
Emboline’s Emboliner has received FDA 510(k) clearance after a randomized head-to-head trial showed similar 30-day clinical outcomes to Boston Scientific’s Sentinel but substantially greater debris capture and higher deployment success. The device now faces a commercial question its pivotal trial could not fully answer: whether protecting more of the circulation ultimately improves patient outcomes.
Medical Devices & Diagnostics
Emboliner captures more TAVR debris, but will FDA clearance translate into fewer strokes?
FDA clears Emboline’s Emboliner for embolic protection during TAVR, opening a U.S. launch after head-to-head testing against Sentinel.
Medical Devices & Diagnostics
Boston Scientific FARAFLEX pivotal trial begins U.S. testing of single map-and-ablate PFA catheter
Texas Cardiac Arrhythmia Institute has performed the first U.S. procedure in Boston Scientific’s 571-patient FARAFLEX pivotal program evaluating integrated mapping and pulsed field ablation for paroxysmal and persistent AF.
Medical Devices & Diagnostics
Why Pulse Biosciences’ 12-month nsPFA data matters in a PFA market dominated by Farapulse and Affera
Boston Scientific owns the PFA market. Pulse Biosciences just posted 90% one-year AF freedom. Is nanosecond PFA a real disruption or an acquisition target?
Medical Devices & Diagnostics
What Boston Scientific’s $14.5bn Penumbra buyout means for stroke and clot intervention markets
Boston Scientific Corporation has announced a definitive agreement to acquire Penumbra, Inc. for approximately $14.5 billion, marking one of its largest acquisitions to date in the medical device sector. The deal, structured as approximately 73 percent cash and 27 percent stock, offers Penumbra shareholders $374 per share and is expected to close in 2026, subject