Medical Devices Today

Republicans Renew Push To Repeal Device Tax; Broad Support Questionable

Article preview from "The Gray Sheet" - January 31, 2011

Republicans in Congress introduced bills last week that would repeal the medical device excise tax before it takes effect in 2013, but few Democrats have jumped on board publicly so far.

TCT 2010: TAVI Takes Center Stage

Article preview from Medtech Insight - December 01, 2010

In the interventional cardiology community, 2010 could certainly be considered a breakthrough year for percutaneous heart valve devices. At two major US cardiology conferences: the American College of Cardiology in the spring, and most recently, the Transcatheter Cardiovascular Therapeutics symposium, held in September, impressive results from randomized trials of transcatheter heart valve replacement/repair devices set the venues abuzz and had physicians speculating about possible near-term paradigm shifts in the way heart valve disease will be treated. The big questions now are how long it will take before these devices reach the US market, and exactly how many US patients are likely to be implanted once they are available.

Cellnovo's Mobile Health Approach to Diabetes Care

Article preview from In-Vivo- December 1, 2010

Cellnovo is working smack at the intersection of two of the hottest areas in medtech: diabetes and mobile health. Aiming to be the iTunes of diabetes care, the firm hopes to transform today's piecemeal management of the disease. The private company has developed an integrated platform designed to ease the burden for patients with type 1 diabetes, their physicians and their families. Cellnovo's system integrates a blood glucose meter, an insulin pump, and a simple interface that makes it easy to gather and share among all interested parties the many parameters associated with diabetes care: diet, level and frequency of blood glucose readings, insulin delivery profiles, degree of physical activity, and health status, for example. Indeed, because success in type 1 diabetes care heavily depends upon the compliance and adherence of patients to numerous daily tasks as they try to live normal lives, the disease is a good test case for the first end-to-end, patient-centric solution.

Nanostring Unveils Its Molecular Diagnostics Strategy

Article preview from Start Up- December 1, 2010

One strategy for growth among analytical platform companies is to leverage its instrumentation sales channel by developing or acquiring diagnostics content. Nanostring is now doing this by in-licensing a gene expression signature for breast tumor typing. And unlike other molecular tests for guiding breast cancer therapy, which are performed in specialty CLIA labs run by their developers, this one will be broadly distributed to hospitals and pathology laboratories globally.

FDA 510(k) Reform Plan Yields Mixed Readings

Article preview from "The Gray Sheet" - January 24, 2011

Readings were mixed on what the ultimate impact will be on the medical device industry and on patient safety from FDA's 510(k) reform plan announced Jan. 19.

Hospitals Up the Ante in Device Purchasing Decisions

Article preview from Medtech Insight - December 01, 2010

In many US hospitals, materials, purchasing, and supply chain executives often have the clout to influence thumbs-up or thumbs-down decisions on most new products that enter the building. That is one major reason why medical device manufacturers are waking up to the fact that so-called "me-too" items and minor upgrades to existing products aren't as acceptable to hospitals as they once were. But in the evolving market in materials office supplies, smart manufacturers with a clear path to working alongside materials executives offer products that keep costs down, add to patient safety, and enhance patient care.

Device M&A; Rebound Continues: With Ardian, Sadra Deals Show Appetite For Big, Early-Stage Acquisitions

Article preview from In-Vivo- December 1, 2010

The year looks to be closing strong in terms of device M&A as the rebound we noted last month has continued, highlighted by the recent acquisitions of Ardian, with its novel percutaneous technology for hypertension (and perhaps other conditions), by Medtronic in what could turn out to be a billion dollar deal, and Boston Scientific's leap into the hot transcatheter valve space with its acquisition of Sadra Medical. At a time when acquirers and investors claim to be looking primarily for more mature, commercial-stage companies, these deals indicate that there remains a robust demand for truly innovative devices that address significant unmet needs and markets.

Medical Device Investing 2010 and Beyond: Time To Challenge the Conventional Wisdom

Article preview from Start Up- December 1, 2010

A new analysis by Aisling Capital and Silicon Valley Bank questions the assumption that bets in medtech companies pay off more quickly and surely than biopharma investments. However, when medical device companies win, they win big.

Medtronic Alters Trial To Resolve Concerns Heart Valves Denied To Some

S&N Says Not Discussing M&A, But Leaves Open Possibility As Suitors Circle
B. Braun Investigated For Questionable Granting Of IV Device Patent
Allergan Seeks Expanded Indication For Weight-Loss Device, Tripling Market
Abbott Glucose Meters Shown In Test To Be Off By As Much As 16 Percent
Guidant-Paid Army Cardiologist Pleads Guilty To Accepting Firm’s Favors
Thermo Fisher Extends Deadline For Dionex Buyout Offer After Weak Response
Boehringer To Sell Medical-Device Polymer Business To Evonik
Medtronic Completes $800 Million Total Acquisition Of Ardian
St. Jude, Zonare Launch Co-Developed Interior-Heart Ultrasound Device
Guidant Guilty Plea In Defibrillator Accepted By U.S. Judge
Roche Diagnostics Seeks To Block Alere From Acquiring Medical Automation

Abbott Sees Absorb Bioresorbable Implant As Stent Market Game Changer

Article preview from "The Gray Sheet" - January 17, 2011

Abbott will commence a 2,000-patient clinical trial by year end to support U.S. approval of its Absorb drug-eluting bioresorbable vascular scaffold as an alternative to conventional coronary stents following an initial European debut.