Despite the COVID-19 pandemic, medical device companies are still working to gain regulatory approvals and launch new devices this year. The pandemic has largely fixed the FDA’s focus on emergency use authorizations (EUAs), leaving more typical device approvals waiting. At press time, the regulatory agency had granted 84 EUAs beginning Feb. 4 and had approved […]
Surgical
Cutera, Senseonics and more receive Paycheck Protection Program loans
A number of medtech companies announced that they received millions of dollars in loans through the Paycheck Protection Program of the Coronavirus Aid, Relief and Economic Security (CARES) Act. Cutera (NSDQ:CUTR), Senseonics (NYSE:SENS), Viveve Medical (NSDQ:VIVE) and Encision (ECIA:ECIA) received approximately $15 million combined through the program administered by the U.S. Small Business Administration amid the COVID-19 pandemic. […]
White House gives elective procedures green light
Shares of two of the largest orthopedic device companies started climbing this morning on news of a new White House recommendation that elective surgical procedures may resume. Shares of Zimmer Biomet (NYSE:ZBH) were up 6.42% to $116.45 apiece in mid-morning trading and those of Stryker (NYSE:SYK) had risen 5.28% to $184.20.on both an inpatient and outpatient basis […]
Intuitive Surgical beats The Street on Q1 results, but faces uncertainty for rest of 2020
Intuitive Surgical (NSDQ:ISRG) posted first-quarter results this evening that beat the consensus forecast on Wall Street — but the company cannot reliably estimate the negative effects of the COVID-19 pandemic. The Sunnyvale, Calif.–based robot-assisted surgery giant reported profits of $314 million, or $2.62 per share, on sales of $1.1 billion for the three months ended March […]
Xenocor wins FDA nod for 5 mm articulating laparoscope
Xenocor announced that it received FDA clearance for its Xenoscope disposable 5mm articulating laparoscope for abdominal and thoracic surgery. The Salt Lake City-based company designed its latest laparoscope to improve image quality, reduce fog, lower hospital costs and reduce bio-hazard risk for the patient and staff. Xenocor’s new Xenoscope includes a disposable 5mm camera on […]
Origami Surgical raises $2.2m for robotic suturing tech
Origami Surgical last week filed an SEC Form D to confirm the sale of more than $2.2 million in an equity offering. The Madison, N.J.-based company, founded this year, filed a new notice for the sale of equity on March 23, 2020, with the intention of the offering lasting less than a year. According to […]
Innovo Surgical raises $1.8m
Recently incorporated Innovo Surgical filed an SEC Form D to confirm that it has raised nearly $1.8 million in an offering of equity and other securities. The Mission Viejo, Calif.-based company, which listed its year of incorporation as 2020, posted the new notice on March 3. The offering includes equity and/or securities to be acquired […]
Smith & Nephew expects Q1 revenue to be down 8% amid coronavirus
Smith & Nephew (NYSE:SNN) announced today that it is withdrawing its 2020 full-year financial guidance and projecting a sizeable decline in first-quarter revenue growth as a result of the COVID-19 pandemic. The London-based medtech giant’s guidance, issued on Feb. 20, assumed a normalization of the coronavirus outbreak early in the second quarter. However, given the rapid […]
Neocis seeks 510(k) nod for Yomi edentulous splint for robotic dental surgery
Neocis announced today that it filed for FDA 510(k) clearance for its Yomi edentulous splint to aid its dental robotic surgical system. The Miami-based company’s new splint is designed to enable the Yomi dental robotic system to go beyond placing implants for partially edentulous patients, with new capabilities for assisting doctors with full arch implant […]
European Commission scrutinizes J&J TachoSil buy
The European Commission said Wednesday that it has opened an in-depth investigation of the proposed $400 million acquisition of Takeda Pharmaceutical’s (TSE:4502;NYSE:TAK) TachoSil surgical sealant patch by Johnson & Johnson (NYSE:JNJ). The commission said it is concerned that the acquisition by J&J’s Ethicon unit may reduce competition and innovation for the supply of dual haemostatic patches, used […]
Conformis furloughs a third of its employees amid coronavirus pandemic
Conformis (NSDQ:CFMS) announced today that it is furloughing a third of its employees and tossed out its 2020 financial guidance amid the coronavirus crisis. The Billerica, Mass.–based orthopedic arthroplasty technology company’s furlough includes approximately 80 employees and substantially all of its temporary workforce, effective today. Conformis said it identified essential and non-essential functions to its business […]