Life Sciences
Top stories summarized by our editors
7/22/2019

The medical device industry lobby hopes the recent and nearly unanimous House vote to repeal the "Cadillac tax" on high-cost health insurance plans is a positive sign for a future repeal of the medical device tax. While it is not yet known whether the Senate will take up the "Cadillac tax" repeal, the House vote "sent a clear message that taxes on our health care system are a bad idea -- and that the case for keeping the medical device tax in place no longer holds water," said AdvaMed President Scott Whitaker.

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MassDevice (Boston)
7/22/2019

Atos will build a computational and data storage infrastructure for a French genomic platform called GCS Auragen. The platform is part of a $752.8 million genome sequencing initiative of the French government to further personalized medicine.

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Atos, French government
7/22/2019

Startup spine imaging firm Precisive Surgical and Carlsmed, a spinal implant company, have completed a merger to develop a personalized surgical workflow system that will work with MIS, traditional and robotic surgical techniques. The platform is designed to permit earlier intervention and implant delivery for complex, multi-level spinal alignment deviation.

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Precisive Surgical, Carlsmed
7/22/2019

Mayo Clinic has invested about $1 million in financing to BioSig Technologies, a cardiac arrhythmia-detection startup. BioSig recently completed first-in-human studies of its Pure EP system for ablation and mapping procedures in a Mayo Clinic cardiac EP lab.

7/22/2019

Corindus has been granted clearance by Australia's Therapeutic Goods Administration to market in Australia and New Zealand its vascular robotic system CorPath GRX. The device is designed to assist in precisely placing devices and stents during complex vascular cases and interventional procedures.

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FDAnews
7/22/2019

Australia's Therapeutic Goods Administration has published a 53-page final guidance on premarket cybersecurity requirements for medical devices and in vitro diagnostics. The report includes six general principles and nine design and construction requirements.

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Regulatory Focus
7/22/2019

Elekta's Unity magnetic resonance radiation therapy system has been cleared by the Canadian Nuclear Safety Commission for clinical use. The system is supported by software that adjusts doses of radiation therapy based on the tumor's size, shape and position and the healthy tissue around it.

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FDAnews
7/22/2019

The FDA has issued a final guidance on the submission of next-generation sequencing data from resistance assessments of antiviral drugs. The guidance discusses the type of data the FDA would like sponsors to provide and discusses acceptable NGS platforms, NGS protocols and data analysis methods.

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FDA
7/19/2019

The World Health Organization has released an updated model list of essential medicines, which now includes 12 new treatments for diseases such as leukemia, melanoma, multiple myeloma, and prostate and lung cancers. The revised list, which is recommended internationally for public health systems, now contains 460 products due to the addition of 23 medicines for children and 28 for adults, and also includes new uses for 26 products already included in the list.

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FDAnews
7/19/2019

In response to President Donald Trump's executive order on kidney care announced this month, the CMS has proposed one mandatory and four optional alternative payment models for treatment of chronic kidney disease. The proposed mandatory end-stage renal disease treatment choices model, which will start next year and end on June 30, 2026, would link Medicare payments to use of home dialysis and successful transplants, while the four optional models would be based on the Primary Care First and Direct Contracting models, and their goal is to delay disease progression and educate and support patients.