The Massachusetts Medical Devices Journal is the online journal of the medical devices industry in the Commonwealth and New England, providing day-to-day coverage of the devices that save lives, the people behind them, and the burgeoning trends and developments within the industry.
They gave him a sword and he handed them the world. When William Hawkins officially flipped the keys to Medtronic Inc. (NYSE:MDT) over to successor Omar Ishrak, he offered a simple message and a gift. The message was clear – don’t lose sight of founder Earl Bakken’s mission to alleviate pain, restore health and extend […]
The recent report of a computer security expert who hacked his own insulin pump got the attention of members of the House Energy & Commerce Committee. This week senior committee members Anna Eshoo (D-CA) and Edward Markey (D-MA) urged the Government Accountability Office to investigate the safety and security of wireless medical devices, citing an […]
The FDA planned a public workshop for mid-September to discuss the recently released draft guidance regarding regulation for mobile medical apps. The guidance includes a fairly narrow subset of medical apps, covering those that are used as accessories to medical devices and those that transform a mobile platform into a regulated medical device. “The use […]
Medtronic Inc. (NYSE:MDT) landed a $1.6 million aid package from the Jacksonville City Council, which is hoping the company will expand its Medtronic Xomed surgical technology facility. “This is exactly the kind of thing we need to be doing in Jacksonville,” Councilman Bill Bishop told members of the Rules Committee during the voting meeting, calling […]
The FDA set an August 23 date for a final rule for three “fallen angel” class III devices to submit premarket applications or be taken off the market as their existing 510(k) cleared status has been revoked. The term “fallen angel” refers to medical devices that were once candidates for the FDA’s fast-track 510(k) review […]
Paulson & Co. Inc. is Boston Scientific Corp.’s (NYSE:BSX) largest shareholder no more, after liquidating its position in BSX completely by selling off some 15 million shares of the Natick, Mass.-based medical device company during the second quarter. The New York-based fund has been steadily selling off its BSX shares for more than a year. […]
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
Abbott (NYSE:ABT) enrolled its first patients in a Japanese trial of the Absorb bioresorbable vascular scaffold. The Absorb stent opens clogged blood vessels and provides support to restore blood flow, and dissolves within about two years. Since the stent dissolves rather than leaving behind a metal scaffold, the treated vessel may be able to regain […]
The cardiac rhythm management industry looks like it needs of a jolt of its own, badly. A look at the earnings releases of two of the big three players in the CRM Market, Boston Scientific (NYSE:BSX) and St. Jude Medical (NYSE:STJ), reveals that the slump in the cardiac rhythm management business is more persistent than […]
The FDA released a new guidance yesterday detailing the agency’s process of making benefit-risk determinations when assessing premarket applications for medical devices for “reasonable assurance of safety and effectiveness.” The agency hopes to provide clarity for both industry and its reviewers by outlining what sorts of factors are taken into consideration when considering PMAs, the […]
The FDA took bold steps to outline expectations for medical device premarket submissions in the release of a new draft guidance that outlines the basic structure for clinical trials. The document attempts to the foundational features of medical device trials, including what types of studies may be appropriate, how to avoid bias in subject or […]
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.
Medtronic Inc. (NYSE:MDT) got a thumbs up for its InterStim sacral nerve stimulation product’s clinical trials. The Minneapolis, Minn.-based device giant published new data on its InterStim device, showing that it reduced episodes of incontinence and increased quality of life at three years follow-up for a majority of patients. Medtronic, ranked 5th on the MassDevice […]
The Institute of Medicine was right to dub the FDA’s 510(k) medical device program unfixable, at least according to the New England Journal of Medicine. The process of using existing or “predicate” devices as the basis for evaluating the safety and effectiveness of a new device is “untenable,” according to an editorial in the respected […]
In the latest volley in the individual insurance mandate lawsuits, a Ninth Circuit court dismissed challenges to the reform measure on the same day that a 11th Circuit court ruled against the law. A three-judge Ninth Circuit panel on Friday dismissed complaints brought by former California legislator Steven Baldwin and nonprofit group the Pacific Justice […]
Shares of Boston Scientific Corp. (NYSE:BSX) traded at unusually high volumes for two straight weeks during the recent roller coast on Wall Street, coming in at more than 120 million trades during the week ending July 29 and topping 140 million the week ending August 5. Last week shaped up to top even those numbers, […]
GI Dynamics officials are still on the down low about their IPO down under, but the company’s offering of more than 72 million shares of stock on the Australian exchange opened yesterday. The Lexington, Mass.-based device company is making available some 72.7 million chess depository interests at a price of A$1.10 per CDIs, a type […]
