Medical Devices Today

Intuitive Surgical Secures New Technologies

Article preview from IN VIVO -  June, 2009 

The economic meltdown that drove many publicly traded share prices into the ground promised to spark a shopping spree for strategic investors looking to score inexpensive assets. The deals largely haven't materialized, but Intuitive Surgical., with more than $800 million in cash reserves and investments, is certainly beginning to nibble. Over the past six months, Intuitive has signed three technology-sharing agreements and bought the assets of a fourth in pursuit of new technologies to help feed future products to sell along side-or potentially inside-its da Vinci surgical systems. Read on...

What Happens After the Device IPO?

Article preview from Start-Up - June, 2009

Investors love to remind everyone that IPOs are financing events, not exiting events. using the mantra to put off Judgment Day for their investments. So how have device companies fared after the recent spate of IPOs. Read more...

Stroke Devices: Facing Challenges Head On

Article preview from Medtech Insight - June, 2009 

The International Stroke Conference, held in San Diego in February 2009, presented several device-based therapies and approaches that could offer improved outcomes for patients that suffer an acute ischemic stroke. The technologies discussed included mechanical thrombectomy devices, laser treatments, and combined therapy using ultrasound, microspheres, and thrombolytic drugs. Read on...

Stryker Sued Over Pumps For Delivering Post-Surgery Pain Drugs

• Stryker Sued Over Pumps For Delivering Post-Surgery Pain Drugs
• Boston Scientific CFO Points To Guidant Buy As Epitome Of Good Deals
• Covidien Gets Canadian Approval For Cardiolite-Based Heart Diagnostic
• J&J Ethicon Unit Breaks Ground With YouTube Promotional For Device
• St. Jude, Medtronic Devices On List Of Comparative-Testing Proposal

MRI Coverage Proposals: A 'Go' For Blood Flow, 'No' For Pacemaker Patients

Full article reprinted from "The Gray Sheet" - July 6, 2009

Use of magnetic resonance imaging to assess heart valve disease in Medicare patients may be an easier proposition for physicians if a June 30 CMS coverage ¹ proposal is adopted. Find out more...

Medtronic's Melody Transcatheter Pulmonary Valve Gets FDA Panel Date

Full article reprinted from "The Gray Sheet" - July 6, 2009

FDA's Circulatory System Devices Panel will review a humanitarian device exemption application for Medtronic's Melody transcatheter pulmonary valve and Ensemble delivery system July 22, according to a July 2 Federal Register notice. Find out more...

FDA Policy For Device Modifications Faces Mounting Scrutiny

Full article reprinted from "The Gray Sheet" - July 6, 2009

Legislators looking for weak spots in FDA's device pre-market review program have honed in on a perceived loophole that allows firms to change existing 510(k) products without notifying FDA. Find out more...

Medtronic, Stryker BMP Products Under Fire In Published Study

• St. Jude Medical Gets FDA Warnings Of GMP Problems At Two Plants
• St. Jude Settles On Malaysia After Two-Country Tug Of War
• Medtronic Brain Stimulator Shows Promise In French Study
• W.L. Gore To Add Engineer, R&D To Staff At Phoenix Plant
• Medtronic, Stryker BMP Products Under Fire In Published Study
• Siemens Healthcare Names Reitermann To Head U.S. Medical Imaging Unit
• Cardinal Health’s CareFusion Spinoff Faces Challenges
• Allergan’s Drug-Carrying Eye Implant Ozurdex Wins FDA Approval

Joint Arthroplasty's High-Tech Future

Article preview reprinted Medtech Insight - June, 2009 

Despite orthopedic surgeons' conservative reputation when it comes to new technology adoption, high-tech devices are increasingly finding a place in this field. There have been recent developments in robotic computer-assisted surgery and other high-tech enabling tools that could lead to wider acceptance of these devices by surgeons better known in the past for eschewing such "frills." Although there are exceptions, most manufacturers seeking success in this market appear to have learned from the mistakes of the past, and many, instead of offering technology for technology's sake, are now trying to provide surgeons with what they really want - products that offer a value-added benefit to their practice. Read more...

Interview with Fred Khosravi

Article preview reprinted from IN VIVO -  June, 2009 

In Vivo interviews device entrepreneur Fred Khosravi about his secrets for success in medical device company creation. Khosravi was part of the ACS organization that eventually became Guidant, where he was on the leading edge of the coronary stent revolution. That experience provided Khosravi with a broad background in interventional cardiology devices that was useful in starting his first company, carotid stent company EndoTex Interventional Systems (which was acquired by Boston Scientific) and several other successful companies. Read more...