Declining sales and the supply & manufacturing issues that have bedeviled Zimmer Biomet (NYSE:ZBH) recently prompted an Argus analyst to downgrade the orthopedic giant’s stock today. Argus analyst David Toung moved ZBH shares from a “buy” to a “hold” rating based on the company’s estimate that it would be the second quarter before it returned to full […]
FDA grants de novo clearance to hemodialysis catheters from Avenu Medical, TVA Medical
The FDA today granted de novo clearance to a pair of companies that make catheters designed for hemodialysis, Avenu Medical and TVA Medical. The federal safety watchdog said the catheters are designed to create an arteriovenous fistula connecting veins and arteries for a less-invasive way to access the vascular system. Avenu’s device is called Ellipsys; […]
GPB Capital puts $21m into CardioFocus for HeartLight catheter launch
CardioFocus landed a $21 million debt investment from GPB Capital and plans to use the proceeds to back the commercial launch of its HeartLight catheter for treating atrial fibrillation. The funding consists of a $21 million senior secured convertible note due to mature in April 2021. CardioFocus, which won FDA approval for its HeartLight Excalibur balloon last month, […]
Breast implant maker Establishment Labs registers for $58m IPO
Breast implant maker Establishment Labs yesterday registered for an initial public offering worth nearly $58 million, saying it plans to use the proceeds to fund a pre-market approval study of its Motiva implants. The FDA granted an investigational device exemption in March for the PMA study and enrolled the first patient the next month, the […]
Analogic shareholders approve $1B go-private deal with Altaris
The $1 billion go-private deal between Analogic (NSDQ:ALOG) and private equity shop Altaris Capital Partners is slated to close tomorrow now that Analogic’s shareholders have approved the deal. Peabody, Mass.-based Analogic said that the $84-per-share deal, announced in April, is worth roughly $1.1 billion. The acquisition passed its first hurdle in the sale late in April, when the […]
Johnson & Johnson hits the Big Apple with latest JLabs site
Johnson & Johnson (NYSE:JNJ) opened its latest life science incubator in New York City, the healthcare giant said today. The 30,000-square-foot JLabs @ NYC is a collaboration between Johnson & Johnson Innovation, New York State and the New York Genome Center. Sited at the genome center in SoHo, the incubator is home to 26 startups and […]
No new trial for Bard in $4m vena cava filter loss
Becton Dickinson & Co. (NYSE:BDX) subsidiary C.R. Bard this week failed to win a new trial after a jury awarded nearly $4 million to the plaintiff in a bellwether product liability lawsuit brought over Bard’s inferior vena cava filter. Plaintiff Sherr-Una Booker was implanted in June 2007 with a Bard G2 IVC filter to mitigate her risk […]
InVivo Therapeutics prices $13m offering
InVivo Therapeutics (NSDQ:NVIV) today priced a public stock offering worth more than $13 million for the neurospinal scaffold it’s developing to treat spinal cord injuries. Cambridge, Mass.-based InVivo said it plans to float some 388,000 shares and another 388,000 warrants at a combined price of $2 per unit, plus 6.2 million pre-funded warrants and 6.2 million […]
Abbott escapes payer’s lawsuit over St. Jude Medical CRM batteries
Abbott (NYSE:ABT) this week escaped a purported class action lawsuit brought by a third-party payer over defective batteries used in subsidiary St. Jude Medical‘s cardiac rhythm management devices. Plaintiff ASEA/AFSCME Local 52 Health Benefits Trust brought the suit last September on behalf of third-party payers, alleging in the U.S. District Court for Northern Illinois that Abbott and St. […]
FDA warns on leak risk with discontinued Endologix stent graft
The FDA yesterday warned of an increased risk of serious endoleaks with a discontinued stent graft once made by Endologix (NSDQ:ELGX). Last September the federal safety watchdog warned physicians about the risk of endoleaks with stent grafts used to wall off aneurysms in the abdominal aorta. The FDA said at the time that the warning was […]
Apollo Endosurgery prices $21m offering
Apollo Endosurgery today priced a stock offering worth nearly $21 million for its line of bariatric and gastrointestinal devices. Austin, Texas-based Apollo said it plans to float roughly 3.75 million shares at $5.50 apiece, for gross proceeds of $20.6 million. The offering also includes a 45-day option for underwriter Craig-Hallum Capital of another 562,055 shares, […]
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