The FDA appears poised to impose a tougher clearance process on manufacturers of high-intensity ultrasound systems for prostate tissue ablation. The agency has issued new draft guidance on clinical testing that manufacturers of these devices must conduct, in accordance with special controls. The draft guidance also outlines recommended clinical data to support 510(k) applications for […]
Wall Street shrugs as Boston Scientific sets growth goals
Wall Street shrugged today after Boston Scientific (NYSE:BSX) set out its long-term financial goals, despite a revenue growth target that’s right in line with the consensus. The Marlborough, Mass.-based medical device maker said it’s eyeing double-digit adjusted earnings per share from 2019 to 2022, on an organic compound annual growth rate of 6% to 9% during […]
ConforMIS lines up $33m financing
ConforMIS (NSDQ:CFMS) said yesterday that it lined up $33 million in financing for its customized joint replacement devices. Innovatus Capital Partners and East West Bank put up $30 million in debt financing and Innovatus took out a $3 million equity position in Billerica, Mass.-based ConforMIS. The proceeds are earmarked for paying down a $15 million term […]
Medtronic covers upsized $4B tender with €5B notes offering
Medtronic (NYSE:MDT) yesterday raised the top end of a debt tender to more than $4 billion, covering the outlay with a €5 billion senior notes offering. Earlier this week the Fridley, Minn.-based medical device giant floated a pair of tender offers for senior notes, one for up to $1.18 billion and a second for up […]
Report: Smith & Nephew mulls shift to U.S. listing
The board of directors at Smith & Nephew (NYSE:SNN) reportedly discussed shifting its stock listing from the U.K. to the U.S., partly to free its CEO from British pay restrictions. The orthopedics and wound care giant last year tapped former Alere chief Namal Nawana to replace the retiring Olivier Bohuon. At Alere, Nawana pulled down […]
Hillrom’s Welch Allyn wins $100m Defense contract
Hillrom (NYSE:HRC) subsidiary Welch Allyn won a Pentagon contract worth $100 million for patient monitoring equipment, the U.S. Defense Dept. said yesterday. Skaneateles Falls, N.Y.-based Welch Allyn beat out 35 other outfits to win the five-year contract, which has a single five-year option after June 24, 2024, the Pentagon said. The contract covers the Army, Navy, Air […]
Transplant Biomedicals touts kidney transport device study results
Transplant Biomedicals (Barcelona, Spain) said the first-in-human clinical trial of its kidney transportation device has yielded positive results. The 32-patient study of Vivian Kidney showed an “excellent safety profile” with no device-related adverse events and no organs being discarded before implantation, the company said. The device was also associated with a low rate of delayed […]
Report: Sharpless, two others in running for FDA chief | Personnel Moves, June 25, 2019
Acting FDA commissioner Dr. Ned Sharpless and at least two others are reportedly in the running to lead the federal safety watchdog, including a Harvard dermatology professor and a physician at a Texas cancer center. Sharpless, the former head of the National Cancer Institute, took over from Dr. Scott Gottlieb as acting commissioner in April. […]
AbbVie to buy Allergan for $6.3B
Pharmaceutical giant AbbVie (NYSE:ABBV) said today it will acquire Allergan (NYSE:AGN) for $63 billion in cash and stock. The purchase is seen as a hedge against the impending expiration of U.S. patents on AbbVie’s blockbuster drug, Humira. AbbVie will pay Allergan shareholders $188.24 per share of Allergan stock, a 45% premium to yesterday’s closing price. […]
Zoll warns on AED Pro defibrillator issue
Asahi Kasei (TYO:3407) subsidiary Zoll Medical this month issued a field advisory for its AED Pro automated external defibrillator after receiving a report that a unit failed during use. Chelmsford, Mass.-based Zoll said its investigation traced the problem to an “isolation breakdown” on an area of the AED Pro’s internal circuit board. “If the isolation breakdown […]
InterVene raises $15m Series B for BlueLeaf venous valve repair device
InterVene said today that it raised a $15 million Series B round for the venous valve repair device it’s developing. South San Francisco-based InterVene touts BlueLeaf as the first catheter-based treatment for deep vein reflux that doesn’t use an implant. It’s designed to form new venous valves using vein wall tissue, the company said. The […]
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