In an article published on MassDevice.com, medical device executives responding to a recent survey said that they expect the new year to be an opportunity to advance the next generation of innovative medical technologies. At the same time, survey respondents predict that regulatory burdens, the need to maximize resources, and an increasingly competitive medical device market environment will be their three biggest challenges this year.

The article can be accessed at the MassDevice.com website.

January 20th, 2012
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In just the past week, Ventana Medical Systems has announced three different collaborations to develop companion diagnostics:

-Aeterna Zentaris Inc. entered into a collaboration agreement with Ventana Medical Systems to develop a companion diagnostic for the immunohistochemical determination of luteinizing hormone-releasing hormone (LHRH) receptor expression, for the Company’s doxorubicin LHRH targeted conjugate compound, AEZS-108. In humans, LHRH receptors are expressed in a significant proportion of endometrial, ovarian, breast, bladder, prostate and pancreatic tumors. AEZS-108 specifically targets LHRH receptors and therefore, could prove to be more efficient in treating patients with these types of LHRH-receptor positive cancers. Phase 2 trials with AEZS-108 for LHRH-receptor positive advanced endometrial and ovarian cancer have recently been completed.

-Syndax Pharmaceuticals Inc. and Ventana Medical Systems entered into an agreement to develop a companion...

January 13th, 2012
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Medtronic Inc. announced FDA approval and U.S. market launch of the first-of-its-kind mySentry Remote Glucose Monitor, which allows a parent or caregiver to monitor from another room a patient’s MiniMed Paradigm REAL-Time Revel System. The remote glucose monitor also marks the launch of a new category of Connected Care solutions that will provide people with diabetes and their caregivers convenient options to access their diabetes management information.

mySentry allows caregivers to see real-time insulin pump status and glucose trends, as well as hear alerts and alarms, at their bedside while an adult or child with diabetes sleeps in his or her own room. This could be especially useful for parents, who could be alerted through a predictive alarm in the middle of the night if their child’s glucose levels are falling, allowing them to take action to prevent an episode of low blood sugar (hypoglycemia). For a caregiver of someone with type 1 diabetes, nighttime...

January 6th, 2012
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Seventh Sense Biosystems Inc. has been awarded a $3.28 million grant from the Bill & Melinda Gates Foundation. The grant is part of the Grand Challenges in Global Health initiative to seek out innovative ideas for diagnostics in the developing world. Seventh Sense’s proprietary Touch Activated Phlebotomy (TAP) technology platform is one of more than twenty Grand Challenges point-of-care diagnostics grants announced today. This Grand Challenges program aims to create technologies and components that can enhance assessment of conditions and pathogens at the point-of-care in a variety of settings.

“We are delighted to be part of this significant initiative to improve healthcare in developing countries. The support of the Gates Foundation underscores the potential of the Seventh Sense approach and enables us to expand our TAP technology to aid in the delivery of better diagnoses in resource-poor areas of the world,” said Doug Levinson, Ph.D., President,...

December 23rd, 2011
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U.S. Senators Chuck Grassley (R-IA), Richard Blumenthal (D-CT) and Herb Kohl (D-WI) introduced legislation to help protect patients from unsafe medical devices and improve the management of recalls. 

The Medical Device Patient Safety Act would give FDA important tools to discover problems with faulty medical devices sooner and to better manage recalls when problems do occur, without slowing down the approval process for new devices. 

The bipartisan legislation would allow FDA to require postmarket clinical studies for medical devices that pose potential safety risks, if they were approved through the expedited 510(k) review process. The bill also would implement Government Accountability Office (GAO) recommendations for improving recalls and give FDA new authority to require conditional clearance pending safety studies for devices reviewed under the fast-track, 510(k) approval process.  

"This reform legislation should be part of the...

December 16th, 2011
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Investor interest in the global IVD market is expected to grow in 2012-2014 following a surge in M&A deal values, an acceleration of companion diagnostics partnerships, and the emergence of new prospects for early detection testing, according to Diagnostics 2011, PwC’s biennial review of the IVD sector.

According to PwC, interest in the IVD market is coming not only from existing players, but also new entrants such as financial investors, life sciences research groups, clinical laboratories and medical technology players. PwC expects the IVD competitive landscape will be redefined by new market leaders and larger deals as players bulk up on market share, but that sustained momentum of companion diagnostics partnerships with pharmaceutical companies will depend on actions by governments, regulators, payers and industry to support diagnostics innovation.

PwC identifies the following five themes that will likely shape future M&A activity in the...

December 9th, 2011
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GE Capital and GE Healthcare, the financial services and healthcare divisions of General Electric Co. announced an investment in C8 MediSensors Inc., a privately held developer of non-invasive continuous glucose monitors for diabetic patients. The investment is being made through the GE healthymagination Fund, an equity fund that makes investments in highly promising healthcare technology companies.

The investment is aligned with GE Healthcare’s expanding focus on disease management solutions that can improve healthcare globally, as well as GE’s broader healthymagination initiative, which focuses on reducing cost, increasing patient access and improving quality in healthcare. Financial terms of the transaction were not disclosed.

C8 MediSensors has combined their proprietary technology with Raman spectroscopy to commercialize a non-invasive glucose monitor that can improve the lives of diabetics by giving them a continuous view of their glucose...

December 2nd, 2011
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Samsung Electronics Co. has acquired the Nexus division of ITC Nexus Holding Company (ITC), a provider of cardiac point-of-care testing solutions.

Nexus develops, manufactures and markets the Cardiac STATus, DECISION Point, and VYENT line of rapid test kits that aid in the diagnosis and monitoring of several cardiovascular diseases.

"This investment represents an exciting opportunity to strengthen Nexus' technological capabilities while enabling Samsung to compete in the cardiac point-of-care testing market," said Yong-chu Bang, Vice President of Samsung Electronics' Health and Medical Equipment (HME) business team. "We welcome the expertise that Nexus brings and believe this partnership will play a vital role in helping Samsung to position itself as a global leader in healthcare technology."

"Samsung has a history of leadership and innovation in high growth sectors and has recently announced a commitment to invest in the medical device...

November 21st, 2011
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Senator John Kerry and a bi-partisan group of Senators have introduced legislation to promote development and streamline the approval process for medical devices in Massachusetts.

The Patient Access to Medical Innovation Act, which Senator Kerry cosponsored along with Senators Al Franken (D-MN), Lamar Alexander (R-TN) and Kay Hagan (D-NC), would allow stronger, more innovative life-saving tools into the market by updating the federal approval process to allow the best experts to weigh in.

FDA requires up to 18 advisory panels be brought in to evaluate new medical technologies when FDA lacks “in house” expertise to do so. Current draconian restrictions on advisory panel members, however, often prevent the top leaders from reviewing a specific device or technology, significantly slowing the approval process. Today’s legislation would allow the top experts in their fields onto those panels by requiring FDA to comply with the same conflict of interest...

November 18th, 2011
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NanoString Technologies Inc. has closed $20 million in a Series D round of equity financing.  New investors include GE, BioMed Ventures and Henri Termeer, former Chairman and CEO of Genzyme Corp. All previous venture investors in NanoString also participated in the financing, including Clarus Ventures, Draper Fisher Jurvetson and OVP Venture Partners.

The proceeds of the financing will be used to continue the growth of NanoString’s life science tools business, as well as advance the development of the company’s first molecular diagnostic product, a breast cancer assay based on the PAM50 gene expression signature. 

This investment in NanoString represents the first by GE’s healthymagination Fund that is aligned with GE Healthcare’s recently announced $1 billion commitment to new oncology R&D.  “NanoString is a good strategic fit with GE Healthcare, given our common focus on oncology,” said Pascale Witz, President...

November 11th, 2011
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