News

iHealth expands its retail, connected medical device empire and looks to move into corporations, hospitals

iHealth has been fast on its feet with a whole lineup of inexpensive, connected products targeting cardiovascular and diabetic health. And while the company has its roots in device manufacturing, it's angling to nab massive consumer sales and starting to look toward corporate wellness and even hospital sales.

UPDATED: Propeller Health gets FDA nod to sell app, sensor with GSK inhalers

Smart inhaler company Propeller Health received FDA clearance to sell its sensor and digital health platform in association with GlaxoSmithKline's Diskus dry powder inhaler for asthma and COPD.

Bloomberg: St. Jude Medical discussing takeover of Thoratec

Industry bigwig St. Jude Medical is discussing a buyout of specialist Thoratec, a maker of left ventricular assist devices, which give heart failure patients awaiting a donated heart a bridge to organ transplantation by pumping their blood in the meantime. Thoratec stock is up 18% to around $58 on the rumor, as of 3 p.m.

University of Cambridge developing 'pill on a string' to diagnose esophageal cancer

The U.K.'s University of Cambridge touted a study which suggests that its swallowable "pill on a string" has utility because it scrapes off numerous cancer cells from the esophagus as it is withdrawn.

Exact Sciences capitalizes on Cologuard approval, reimbursement with $179M follow-on

Exact Sciences had a great 2014--it garnered an FDA approval for the first stool-based DNA colorectal cancer screening test in August and snagged reimbursement approval for a specific patient population served by the Centers for Medicare & Medicaid Services (CMS) in October.

Implanting a titanium tube inside damaged bones improves procedure to ward off amputations

A titanium rod implanted inside a bone can improve limb-lengthening procedures that are used to prevent the need for limb amputation, a study in the journal Clinical Orthopaedics and Related Research co-published by Loyola University orthopedic surgeon Dr. Mitchell Bernstein found.

FDA warns of recalled oxygen system regulator that could to lead to canister explosions

The FDA dubbed Western Enterprises' Oxytote Oxygen System regulators potentially deadly, deeming the corrective action of its device a Class 1 recall, reserved for situations "in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death."

Channel Medsystems raises $23.9M for handheld cryothermic uterine ablation device

Emeryville, CA-based startup Channel Medsystems has raised $23.9 million out of a potential total of $29.5 million, according to an SEC filing. The financing is the company's largest to date by far--in similar filings it said it had raised $6 million in debt last year and almost $10 million in equity in 2013.

Profound Medical partners with Philips just after reverse merger

Profound Medical went public on the Toronto Stock Exchange last month and raised $25 million in June. Now, it's partnered with Royal Philips to develop its novel, minimally invasive prostate gland ablation tool to be used on Philips' MRI systems.

UPDATED: Boston Scientific faces reimbursement hurdles for lung-searing asthma treatment

Boston Scientific had high hopes for its electrode-tipped catheter treatment for asthma after snatching up the system in 2010 through its $193.5 million purchase of Asthmatx. But the company is hitting a wall with the product as insurers question the treatment's cost-effectiveness and safety.

UCLA adopts startup cleaning system to help stop spread of superbugs via duodenoscopes

Upstart Langford IC Systems claims that it's launching the only system that meets FDA standards for reprocessed medical device cleanliness. Its first buyer is the Ronald Reagan UCLA Medical Center in Los Angeles, which reported two patient deaths and several infections earlier this year due to insufficiently disinfected duodenoscopes, which are a type of endoscope for examining the duodenum.

Blood-based liquid biopsies are the new frontier in cancer diagnosis

Guardant Health is one of the leaders in liquid biopsies for cancer diagnosis, which involve blood draws rather than invasive procedures to obtain tumor samples. Backed by more than $100 million in VC funding, the company is now processing about 1,000 samples per month.

Study: Angioplasty can be 5 times costlier in one hospital than another one in the same city

Insurer Blue Cross Blue Shield revealed a study that found wild variations in the cost of angioplasties with or without stenting, adding to the growing body of evidence that the U.S. healthcare market is not functioning well, at least at least at the basic function of setting a consistent price for the same procedure.

Boston Scientific heads to the clinic with its first bioabsorbable, drug-eluting coronary scaffold

Boston Scientific has started a study of its first resorbable, drug-eluting scaffold system to treat atherosclerotic coronary lesions. It incorporates aspects of the company's Synergy System, which has a resorbable polymer and everolimus drug-coating, that the device maker expects will be approved by the FDA during the fourth quarter.

HeartWare to commence CE mark trial of the world's smallest blood pump

HeartWare announced the initiation of its CE mark trial for the next-generation MVAD blood pump for heart failure patients, touting the investigational device's small size and ease of implantation.

 

FDA approves Abbott 3-D Lasik system to improve accuracy, expand indication

The U.S. Food and Drug Administration has approved the iDesign Advanced WaveScan Studio System from Abbott Laboratories. The company has already launched the system, which is based on a 3-D map of the eye that's expected to improve the accuracy of Lasik procedures.

NIH-backed scientists develop wireless, remote-controlled brain implant

Amid growing interest in innovative neurological devices to treat brain disorders, scientists supported by the National Institutes of Health (NIH) are developing a wireless, remote-controlled probe that could inject drugs and highlight neurons inside the brain.

Stryker to buy Turkish partner in its second hospital bed acquisition in 2015

Stryker has only disclosed plans for two acquisitions this year--both for private, international, hospital bed makers. The latest is an all-cash deal for Turkish hospital bed, stretcher and patient room furniture and accessory maker Muka, which is headquartered in Kayseri, Turkey.

Early study results indicate EndoStim's implant is effective for treating acid reflux

St. Louis-based EndoStim, the maker of a device that uses electrical stimulation to treat acid reflux, has published interim results it said demonstrates the safety and efficacy of its minimally invasive LES therapy.

UPDATED: Hospitals launch trial to test AliveCor's iPhone-enabled ECG for diagnosis of heart attacks

Utah's Intermountain Health Care will simultaneously test emergency room chest pain patients with two encephalograms, a standard 12-lead one, and Fierce 15 member AliveCor's Mobile ECG, which connects to the back of a smartphone.