FDA has designated Hillrom’s recall of its Liko Multirall 200 overhead lift as Class I, its most serious level. Hillrom (NYSE:HRC) initiated the recall on Dec. 18, 2020. It involves 11,600 devices, which are used to move patients from room to room. The recalled devices have a risk of the Q-link strap locks not attaching to […]
Cordis recalls some Precise Pro RX carotid stent systems
Cordis, a Cardinal Health (NYSE:CAH) subsidiary, is recalling and removing certain lots of its Precise Pro RX carotid stent systems. The Precise Pro RX carotid stent system, which is used in patients with stenotic lesions of the carotid arteries, has the potential for the distal tip to become separated from the wire lumen on certain lots […]
The worst catheter-based device recalls of 2020
The U.S. saw nine serious medical device recalls related to catheters in 2020 — up from four the previous year, according to the FDA. FDA in 2020 reported a total 33 medical device recalls at its most serious Class I level, down from 49 in 2019. The list of the most serious catheter-based device recalls […]
FDA panel votes against BD Lutonix drug-coated balloon for below-the-knee
An FDA advisory panel voted against a favorable recommendation for BD‘s Lutonix catheter-based, drug-coated balloon for use below the knee. The FDA’s Circulatory System Devices Advisory Panel yesterday voted 15-to-2 in favor of the issue of safety when Lutonix is used as intended and voted 15-to-2 against the issue of a reasonable assurance of effectiveness. The […]
Henry Schein One names new CEO
Henry Schein One, a joint venture of Henry Schein (NSDQ:HSIC) and Internet Brands, this week announced that it has appointed Mike Baird as CEO. Baird will be responsible for driving the dental software business’s growth while developing more seamlessly integrated products, according to the company. “Taking on this role with Henry Schein One is an exciting […]
FDA gives ankle implant humanitarian nod
Additive Orthopedics yesterday said it received FDA humanitarian device exemption for its Patient Specific Talus Spacer to treat avascular necrosis of the talus. The Patient Specific Talus Spacer will be available as a humanitarian use device to treat avascular necrosis of the ankle joint, which is a serious condition that causes the death of bone […]
FDA clears FX Solutions stemless anatomic shoulder replacement
FX Solutions today announced that it received FDA 510(k) clearance for its Easytech stemless anatomic shoulder replacement. The Easytech anchor base allows the device to fit peripherally inside the cortical bone where bone quality is optimal for fixation. It is intended to treat a severely painful and/or disabled shoulder joint with a functional rotator cuff […]
Avanos Medical rises on Street-beating Q4 results
Avanos Medical (NYSE:AVNS) posted fourth-quarter results that beat the consensus forecast on Wall Street. The Alpharetta, Ga.-based company reported losses of -$47.2 million, or -99¢ per share, on sales of $185 million for the three months ended Dec. 31, 2020, for a sales loss of 2.53% compared with Q4 2019. Adjusted to exclude one-time items, earnings […]
Cutera beats The Street in Q4 results
Cutera (NSDQ:CUTR) posted fourth-quarter results that beat the consensus forecast on Wall Street. The Brisbane, Calif.-based company reported profits of $2.2 million, or 12¢ per share, on sales of $49.9 million for the three months ended Dec. 31, 2020, for a bottom-line sales growth of 9.5% compared with Q4 2019. Earnings per share were 12¢, 23¢ […]
Organogenesis names new chief financial officer
Organogenesis this week said it appointed David Francisco as the company’s chief financial officer, effective Feb. 15. Francisco replaces Henry Hagopian, who will move on to become the company’s senior VP of finance and treasurer. “I am pleased to welcome Dave to the Organogenesis executive leadership team,” president and CEO Gary Gillheeney said in a […]
Stryker sells T/Pump product line to C2Dx
C2Dx today announced that it has acquired Stryker’s T/Pump product line for an undisclosed amount. The T/Pump product line provides localized temperature therapy for pain relief and patient comfort. It is used for orthopedic conditions, acute injuries, chronic pain and muscle strains. It can also be used for skin trauma, burns, contusions and other localized […]