Article reprinted from "The Gray Sheet" - March 29, 2010
FDA should have no reason to rescind 510(k) substantial equivalence decisions for marketed devices except in extreme cases of fraud, device industry lobbyists said in recent comments to FDA. Read more...
Continue reading "Device Stakeholders Debate Whether FDA Can, Or Should, Revoke 510(k)s " »
Full article reprinted from Start Up - February/March 2010
A year ago, things looked bleak everywhere, including devices. But investors and executives battened down the hatches, tightened their belts, and adopted every other conceivable austerity-tied cliché. Things now are beginning to look upa little. Read more...
Continue reading "Device Prom Song: Looks Like We Made It" »
Article preview reprinted from IN VIVO - February/March, 2010
Alliance dollars were low in January, with only three biopharma deals reaching a potential deal value of $100 million or more, led by Ipsen and Inspiration's collaboration in hemophilia, worth $518 million. The bigger M&A dollars were seen in the device and diagnostic sectors, including Medtronic's take-out of CV device firm Invatec and its affiliates for $500 million. Both biopharma and device financing were down compared with December. Read more...
Continue reading "Deals in Depth: January 2010" »
Article preview reprinted from Medtech Insight - February 2010
This article was excerpted from "Top Device Stories of 2009: A Year of Economic Revival and Regulatory Risk," IN VIVO, January 2010. Read more...
Continue reading "Dealmaking in 2009: A Look Back and A Glance Ahead" »
Article reprinted from "The Gray Sheet" - March 22, 2010
FDA raised concerns about the preclinical and clinical data used to support 510(k) clearance of ReGen Biologic's Menaflex knee repair device ahead of an unprecedented March 23 advisory panel to reconsider FDA's original clearance decision. Read more...
Continue reading "FDA Questions Data Supporting ReGen's Menaflex Ahead Of 510(k) Re-Review " »
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Special Report from “The Silver Sheet” When Is an iPhone a Medical Device? A
special report from “The Silver Sheet” on increasing FDA regulation of consumer
electronics and software used in medical devices and electronic health records.
FREE FOR A LIMITED TIME!
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Just months after selling off its Ovion Eclipse female sterilization assets to Conceptus, American Medical Systems Holdings (gynecological and urological devices) has now divested its Her Option global endometrial ablation product line to CooperSurgical (gynecological devices) for $20.5mm in cash. Read more...
Continue reading "AMSH divests Her Option to CooperSurgical for $20.5mm" »
Article preview reprinted from Medtech Insight - February 2010
Regardless of the final shape of health care reform legislation, there is little doubt that the swirling debate around that issue has highlighted an unambiguous need to reduce health system costs, increase efficiency, and improve patient outcomes. This is particularly true for high-cost diagnostics in crucial areas like cardiac care. The focus on fast-rising care costs has ratcheted up the pressure to reduce the number and fine-tune the quality of cardiac imaging procedures. And perhaps nothing signifies change in this area more than the introduction of comparative effectiveness research into the equation in the search for standards of care. Read more...
Continue reading "Cardiac Imaging and CER: The Search for Efficiency" »