MedAlliance this week said it received FDA breakthrough device designation for its Selution SLR sustained limus release drug-eluting balloon catheter. Selution SLR is designed to treat atherosclerotic lesions in native coronary arteries. The breakthrough designation was awarded for its design of improving luminal diameter in patients with atherosclerotic lesions. Get the full story on our […]
Medtronic launches DCB for dialysis patients in Japan
Medtronic (NYSE:MDT) this week said it launched its first drug-coated balloon in Japan for patients undergoing hemodialysis. The company launched its In.Pact AV drug-coated balloon, which is indicated for the treatment of obstructive lesions up to 100 mm in length in the native arteriovenous dialysis fistulae in patients with end-stage renal disease and undergoing hemodialysis. It […]
Acuitive Technologies gains FDA nod for ligament reconstruction devices
Acuitive Technologies this week announced that it received FDA 510(k) clearance for its Citrespline and Citrelock ligament reconstruction devices. The two systems are designed to firmly engage tendons and ligaments with a bone tunnel while preserving the integrity of the soft tissue during insertion of the device, according to the company. Citrespline and Citrelock are […]
Alphatec posts mixed-bag Q4 results
Alphatec (NSDQ:ATEC) posted fourth-quarter results that beat the revenue consensus on Wall Street but missed on earnings. The Carlsbad, Calif.-based company reported losses of -$26.8 million, or -35¢ per share, on sales of $43.9 million for the three months ended Dec. 31, 2020, for a sales growth of 35.9% compared with Q4 2019. Earnings per share […]
Capsule lands Frost & Sullivan award for remote ventilator monitor
Frost & Sullivan today announced that it awarded Capsule with a 2021 New Product Innovation Award. Capsule received the award for its Ventilated Patient Surveillance workstation that helps frontline healthcare providers identify patients in respiratory distress. It extends the reach of intensive care unit staff over the full range of critical care patients. The workstation […]
Philips debuts AI-enhanced imaging platform
Royal Philips (NYSE:PHG) today said it launched its AI-enabled Precise Suite for its Incisive CT platform. The Precise Suite delivers smart workflows from image acquisition through reporting with AI-enabled image reconstruction, automated patient positioning, motion-free cardiac image capture and real-time interventional guidance, according to the company. The artificial intelligence helps streamline and automate workflows to maximize […]
Conformis dips 9% on Street-beating Q4 results
Conformis (NSDQ:CFMS) posted fourth-quarter results that beat the earnings consensus on Wall Street and matched on revenue. The Billerica, Mass.-based company reported losses of -$6.6 million, or -8¢ per share, on sales of $16.7 million for the three months ended Dec. 31, 2020, for a sales loss of -16.1% compared with Q4 2019. Earnings per share […]
TransMedics jumps on Street-beating Q4 results
TransMedics (NSDQ:TMDX) posted fourth-quarter results this week that beat the consensus forecast on Wall Street. The Andover, Mass.-based company — a maker of transplant organ preservation tech — reported losses of -$6.3 million, or -23¢ per share, on sales of $7.6 million for the three months ended Dec. 31, 2020, for a sales growth of 25% […]
FDA clears Neurolief’s noninvasive neuromod tech to treat migraines
Neurolief today announced that it received FDA clearance for its Relivion noninvasive neuromodulation system to treat migraines. The noninvasive, multi-channel brain neuromodulation system’s creators designed it to treat acute migraines from home. It is a headset that administers personalized care to patients by delivering stimulation to six branches of the occipital and trigeminal nerves through […]
Ambu single-use endoscope wins Frost & Sullivan innovation award
Frost & Sullivan today announced that it awarded Ambu with a 2021 Global New Product Innovation Award. Ambu received the award for its single-use flexible endoscopes that are designed to make the devices safe, affordable and accessible. It has aView and aBox all-in-one video displays that eliminate the traditional video endoscopy tower size and expense to be […]
SeaSpine ticks up on 6.2% sales growth in Q4, reports losses
SeaSpine Holdings (NSDQ:SPNE) posted fourth-quarter results that missed the consensus forecast on Wall Street. The Carlsbad, Calif.-based company reported losses of $10.3 million, or -37¢ per share, on sales of $46.4 million for the three months ended Dec. 31, 2020, for a sales growth of 6.2% compared with Q4 2019. Earnings per share were -37¢, 12¢ […]
