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. […]
Abbott CardioMEMS sensor nearly halves heart failure hospitalizations, study says
A recent European study found that the Abbott CardioMEMS HF System resulted in a 44% reduction in heart failure hospitalizations. Abbott also reported today that the study found an improvement in patient-reported quality-of-life scores as early as three months with the implantable remote monitoring sensor. Heart failure is a global health challenge affecting more than […]
Hologic wins FDA clearance for COVID-flu-RSV assay
Hologic today announced FDA 510(k) clearance of its Panther Fusion SARS-CoV-2/Flu A/B/RSV assay. The clearance comes after a winter in which the U.S. and other countries dealt with a “tripledemic” of COVID-19, influenza, and RSV. In February, the FDA granted an emergency use authorization for a COVID/flu/RSV test from BD. “This past winter, we saw […]
Abbott wins FDA approval for next-gen TactiFlex ablation catheter
Abbott today announced FDA approval of its TactiFlex Ablation Catheter, Sensor Enabled, which the company describes as the world’s first ablation catheter with a flexible tip and contact force technology. The TactiFlex catheter also integrates with Abbott’s EnSite X EP System, enabling physicians to visualize heart anatomy more precisely, according to the company. The result […]
Cook Medical is laying off 500 workers amid strategic realignment
Cook Medical announced today that it will lay off 500 workers — about 4% of its global workforce. In a message to employees posted on the Bloomington, Indiana–based medtech company’s website, Cook Medical President Pete Yonkman described the layoffs as the “most difficult decision we have had to make in support of our strategy.” “The […]