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QUOTED.

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QUOTED. Jan. 18, 2019. George Savage.

Proteus Digital Health announced a new partnership with Minneapolis-based Fairview Health Services and the University of Minnesota Health to prescribe "digital capecitabine," encapsulating the common chemotherapy drug with Proteus' sensor, to colorectal cancer patients. The goal is to achieve medication adherence, leading to enhanced treatment and outcomes, through home-based monitoring. See what George Savage, Proteus' co-founder and chief medical officer, had to say about the new digital oncology program here.

Quoted Commercial

QUOTED. Jan. 17, 2019. Nicholas Berg.

New Mexican president Andrés Manuel López Obrador, a member of the National Regeneration Movement (MORENA) party, has swept the office on an anticorruption platform. Some observers expect his efforts to include reforms and increased regulation touching the medical device sector. Nicholas Berg, an attorney with Ropes & Gray, said that in the past Mexico has made limited efforts to combat public corruption. See his advice for medtech companies planning on doing business in Mexico here.

Mexico Compliance

QUOTED. Jan. 16, 2019. Bradley Thompson.

US FDA is taking a cautious approach to rolling out the test phase of its pre-certification program for digital health products to keep it within legal limits. See what Bradley Merrill Thompson, an attorney at Epstein Becker & Green, had to say about the limited scope of the current plan here.

Quoted Digital Health

QUOTED. Jan. 14, 2019. Jos Van Vroonhoven.

Jos Van Vroonhoven, a senior manager for standardization for Philips Healthcare and the convener of a joint working group that is revising risk management standard ISO 14971, said the document was upgraded to strengthen benefit-risk language and make its recommendations more clear. See what he had to say here.

Quoted Risk Management

QUOTED. Jan. 11, 2019. Ben Newton.

GE Healthcare is collaborating with Vanderbilt University Medical Center to develop AI-powered diagnostic tools for cancer care. Ben Newton, GE Healthcare's chief digital officer, explained that GE hopes the partnership will help GE become a leader in precision medicine by developing algorithms and artificial intelligence systems that can predict adverse events in cancer patients.

Quoted Deals

QUOTED. Jan. 10, 2019. Scott Gottlieb.

FDA will soon begin real-world testing of its "pre-cert" program for health software to find out if the program can be carried out within the agency's current regulatory authorities. FDA commissioner Scott Gottlieb believes it can be.

Quoted FDA

QUOTED. Jan. 9, 2019. Niall Dickson.

The UK's National Health Service issued a long-anticipated plan this week outlining significant structural changes it envisions for the country's health-care system. Niall Dickson, who heads the NHS Confederation, says it is high time for changes in how NHS and industry work together.

Quoted Market Access

QUOTED. Jan. 8, 2019. Johnathan Lancaster.

The UK's National Institute for Health and Care Excellence (NICE) added Myriad Genetics' EndoPredict test to its recommendations for breast-cancer treatment as new data show the long-term prognostic value of the EndoPredict test in guiding therapy for many of these patients. See what the firm's chief medical officer has to say about it here.

Quoted Innovation

QUOTED. Jan. 7, 2019. Bonnie Anderson.

Diagnostics firm Veracyte signed a deal to combine clinical study cohorts with Johnson & Johnson to accelerate development of two nasal swab tests for early detection of lung cancer. See how CEO Bonnie Anderson describes the arrangement here.

Quoted Deals

QUOTED. Jan. 4, 2019. James Beck.

A key recent decision by the Arizona Supreme Court could help shore up protections from patient-injury lawsuits for device companies that were put under question by an earlier court case. See what attorney and federal preemption expert James Beck had to say about it here.

Quoted Legal Issues

QUOTED. Jan. 2, 2019. Anne Blackwood.

There are some significant bright spots for the UK medtech innovation system, but more work needs to be done with the National Health Service, says Anne Blackwood, who runs an organization that works collaboratively with NHS and device firms to accelerate medical advancements.

Quoted United Kingdom

QUOTED. Dec. 21, 2018. Todd Newton.

ReShape Lifesciences has acquired the Lap-Band adjustable gastric band surgery system from Apollo Endosurgery in exchange for $17m and the ReShape Balloon intra-gastric bariatric product line. See what Apollo CEO Todd Newton said about the deal here.

Quoted Companies

QUOTED. Dec. 20, 2018. Chris Harvey.

The public can now search the new International Medical Devices Database, which houses more than 700,000 reports of device recalls, field safety notices and safety alerts from 11 countries. See what Chris Harvey, director of recall solutions for consulting firm Stericycle, said about the database here.

Quoted Safety

QUOTED. Dec. 19, 2018. William Maisel.

The acting compliance office chief for US FDA's device center, William Maisel, was giddy about the growth and popularity of the Medical Device Single Audit Program during a recent Food & Drug Law Institute conference in Washington, DC. See what he said about MDSAP here.

Quoted FDA

QUOTED. Dec. 18, 2018. Scott Gottlieb.

A new report from US FDA concludes, for the most part, that the benefits of a slew of non-device software functions not regulated by the agency outweigh their risks. The report sends a signal to industry that regulators are happy with the current situation and have no incentive to expand their oversight of such products. See what FDA Commissioner Scott Gottlieb said about it here.

Quoted Digital Health
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