tag:typepad.com,2003:weblog-537311 2012-06-04T14:46:58-04:00 The Latest News In Medical Devices and Diagnostics. From Elsevier Business Intelligence, Windhover Information and Medtech Insight - The ULTIMATE free weekly device e-newsletter. TypePad tag:typepad.com,2003:post-6a00d83452f00669e2016767115a8c970b 2012-06-04T14:46:58-04:00 2012-06-04T14:48:22-04:00

Legislation to repeal the impending medical device excise tax will be sent to a vote on the House floor, raising the profile of the tax as a congressional election issue even as major impediments to repeal remain in the Senate. Meanwhile, the Supreme Court health care reform ruling looms.

Josh tag:typepad.com,2003:post-6a00d83452f00669e2016766efdb3c970b 2012-05-30T14:33:39-04:00 2012-05-30T14:33:39-04:00

A roundup of recent medtech mergers & acquisitions, strategic alliances, and financings.

Josh tag:typepad.com,2003:post-6a00d83452f00669e2016305fbfc1b970d 2012-05-30T14:15:14-04:00 2012-05-30T14:15:14-04:00

Haldor Advanced Technologies Ltd.’s ORLocate surgical instrument tracking and asset management system uses RFID to automatically track, trace, monitor and manage the life cycle of instruments and consumables within the hospital – before, during and after a surgical procedure.

Josh tag:typepad.com,2003:post-6a00d83452f00669e2016766efbe26970b 2012-05-30T14:07:03-04:00 2012-05-30T14:07:03-04:00

Brief profiles of these recently formed companies: 3D Biomatrix, ADC Therapeutics, GeneCentric Diagnostics, IDx, InControl Medical and Intrepid Therapeutics.

Josh tag:typepad.com,2003:post-6a00d83452f00669e2016766e97ddf970b 2012-05-29T13:32:03-04:00 2012-05-29T13:53:10-04:00

FDA user fee and reform bill sails through Senate on 96-1 vote. House plans to take up its similar legislation this week.

Josh tag:typepad.com,2003:post-6a00d83452f00669e2016305bc7fb0970d 2012-05-23T10:43:13-04:00 2012-05-22T17:45:01-04:00

Pfizer and Zhejiang Hisun Pharmaceutical together invested $545 million to create a Chinese generics joint venture. Dainippon Sumitomo Pharma expanded its cancer pipeline though the acquisition of Boston Biomedical. Driven by a large amount of FOPOs, biopharma financing totaled $1.8 billion in February, while device companies raised $248 million.

Josh tag:typepad.com,2003:post-6a00d83452f00669e20168ebb21f8b970c 2012-05-22T17:59:08-04:00 2012-05-22T17:59:25-04:00

There are signs that the field of deep brain stimulation (DBS) has gained a certain momentum of late: three start-ups raised venture rounds in 2011 and there have been two acquisitions in the space within the past year. DBS enables the giants in cardiac rhythm management – Medtronic, St. Jude Medical, and Boston Scientific –to leverage existing technology platforms from CRM to address a new area once served primarily by drugs, and start-ups can help them by validating new disease targets and increasing procedural accuracy and efficiency. The space is appealing because with a single platform, companies can address several diseases with large populations, such as depression and Alzheimer’s disease. But the opportunities remain far from certain with this highly complex technology.

Josh tag:typepad.com,2003:post-6a00d83452f00669e2016305bc8c51970d 2012-05-22T17:51:23-04:00 2012-05-22T17:52:35-04:00

Central venous catheters are commonly employed to deliver long-term dialysis, nutrition and chemotherapy, but nearly 10% of patients have an upper-extremity venous occlusion that renders the vein impenetrable by standard access techniques. When access is not possible through traditional “outside-in” routes, Bluegrass Vascular Technologies’ Surfacer system allows for central venous access through the femoral vein in the leg. The device features a bullet-shaped catheter tip with a proprietary side-exit needle that allows the physician to enter into the occlusion and create a new tissue channel, from the inside out.

Josh tag:typepad.com,2003:post-6a00d83452f00669e2016766a7157e970b 2012-05-21T13:43:25-04:00 2012-05-21T13:43:25-04:00

The Medicare Evidence Development & Coverage Advisory Committee was charged May 16 with helping CMS better define the evidence threshold under which the agency should or should not pursue a coverage- with-evidence-development policy.

Josh tag:typepad.com,2003:post-6a00d83452f00669e20167668aace2970b 2012-05-16T13:54:35-04:00 2012-05-16T13:54:35-04:00

Transcatheter LAA closure devices are starting to amass the level of data required to demonstrate their safety and effectiveness, and, if all goes well, the long-awaited FDA approval of the first such device – Boston Scientific’s Watchman – could finally occur sometme next year. Although LAA closure devices have already taken off in some European countries, US physicians continue to struggle with lingering uncertainties, about the learning curve, procedural safety and how LAA closure will stack up against newer anticoagulant drugs. Regardless of how these issues are eventually resolved, industry leaders see a big opportunity for a successful device in the LAA closure space, with market estimates of $1 billion considered conservative by some.

Josh