Illumina (NASDAQ: ILMN) announced today that its board has elected Hologic CEO Stephan MacMillan to fill a new seat and become its non-executive chair. Edwards Lifesciences CFO Scott Ullem will fill a second new seat — bringing the number of board seats to 11 at the San Diego–based DNA sequencing and array-based tech developer. The […]
Bayer is making a big digital health play
Bayer announced that it has launched a business unit that will focus on precision digital health products across a range of everyday health categories. Bayer will prioritize developing digital solutions that enable people to make more informed health choices based on personal insights and novel delivery mechanisms, the company said in a news release posted […]
iRhythm has an FDA warning letter over Zio AT quality systems
iRhythm stock is down today on news of an FDA warning letter involving its Zio AT mobile cardiac telemetry device. In a Form 8-K filed with the SEC yesterday, iRhythm said it received the warning letter on May 25. The warning letter resulted from an FDA inspection at the company’s Cypress, California facility that concluded […]
Exactech announces global release of next-gen GPS Shoulder
Exactech will mark the global release of the latest version of its ExactechGPS shoulder surgery navigation software at the annual Shoulder Masters Course in Amsterdam later this week. The launch is taking place in EMEA and APAC countries. It follows the first surgery in the United Arab Emirates earlier this month, leveraging the company’s Active […]
FDA clears Think Surgical handheld robotic knee surgery device
Think Surgical announced today that it’s received FDA 510(k) clearance for its TMINI miniature robotic system that assists with total knee surgeries. Here’s how Fremont, California–based Think Surgical described the TMINI system in its news release: “The TMINI system includes a wireless robotic handpiece that assists surgeons in performing total knee replacement. Following a CT-based […]
A veteran Medtronic executive takes a new role at Baxter
Medtronic Cardiovascular Diagnostics and Services President Julie Brewer has left for a new position at Baxter. Brewer announced on LinkedIn near the end of last week that she has joined Baxter as President of the Patient Support Systems, Global Surgical Solutions and Care Communications team. “Baxter is a great company with a wonderful purpose of […]
HeartBeam partners with Samsung to boost at-home cardiac care
HeartBeam has announced a strategic alliance agreement (SAA) with global tech giant Samsung. The alliance, announced today, builds upon an existing SAA between Samsung and Livmor, whose assets HeartBeam acquired earlier this year. Livmor created the FDA-cleared wearable Halo atrial fibrillation detection system — an FDA-cleared, Samsung-Galaxy-watch-based arrhythmia detection tool. Meanwhile, HeartBeam recently secured a […]
Medtronic faces a wait-and-see attitude from analysts
Medtronic stock continues to decline today — a day after it underwhelmed The Street with its growth projection for its new fiscal year. MDT shares were down more than 2% to $81.58 apiece by midday today — a day after the stock fell another 2% in value. Meanwhile, MassDevice’s MedTech 100 Index — as well […]
Neuralink says FDA has OK’d a human trial
Elon Musk’s Neuralink says the FDA has approved a first-in-human clinical trial for its brain-computer interface technology. Neuralink said on Twitter yesterday: “We are excited to share that we have received the FDA’s approval to launch our first-in-human clinical study! This is the result of incredible work by the Neuralink team in close collaboration with […]
Medtronic stock down as growth projections underwhelm
Medtronic today reported fourth-quarter results that beat the consensus forecast on Wall Street amid accelerating revenue growth. The world’s largest medical device company also announced an acquisition, planning to pay roughly $738 million for South Korea–based EOFlow and its EOFlow insulin delivery patch that a user can control using their smartphone. However, its forecast for […]
Artivion gains FDA approval for PerClot, starts transfer to Baxter
Artivion today announced FDA premarket application (PMA) approval of its PerClot absorbable hemostatic system designed to control bleeding in specific surgical procedures. The Atlanta-based company will transfer full ownership to Baxter , following a sale agreement that occurred in July 2021. Artivion anticipates receiving an $18.75 million milestone payment under the terms of the agreement. […]