Here are five we expect to hear more about next year.
The medical device industry has been touting the potential advantages of bioresorbable stents for what feels likes ages. But the novel technology hasn’t yet made it over the hump to gain approval in the United States. That could soon change, however.
Abbott’s Absorb is currently undergoing a clinical trial in the United States.
In April, Abbott Laboratories completed enrollment of three clinical trials to support approval of its Absorb bioresorbable scaffold in the United States, Japan, and China. The product received CE Mark in 2011 and is already available in more than 60 countries worldwide. Competitor Elixir Medical Corp. hit a major milestone this year as well when it obtained CE Mark for its DESolve 100 Novolimus-eluting coronary scaffold in May.
“Reimbursement is likely to improve adoption in the next few years,” says Sowmya Rajagopalan, advanced medical technologies research manager with Frost & Sullivan, adding that could push the global market for bioresorbable stents over $1 billion by 2020.
In October 2009, cardiologists Ron Waksman and Rajbabu Prakala, from Washington Hospital Center in Washington, DC, posited that drug-eluting balloons could make balloon catheters the “comeback kid of percutaneous coronary intervention.” Balloon angioplasties, after all, have largely been outmoded by intracoronary stenting and drug-eluting stents.
The Lutonix 035 is the first FDA-approved drugeluting balloon.
Their prediction appears to be ringing true.
“Drug-eluting balloons are the next big thing in vascular interventions,” Rajagopalan says. “With the first FDA approval in 2014, the global market for this product is likely to double in the next few years.”
C.R. Bard nabbed the first U.S. approval of a drug-eluting balloon catheter in October with its Lutonix 035, and other companies are hot on its heels. Medtronic, for one, is targeting 2015 for approval of its much-hyped IN.PACT Admiral drug-coated balloon.
Imagine if brain tumor removal required only mild sedation and no hospital stay. That’s the promise of focused ultrasound technology, which combines real-time magnetic resonance imaging and an ultrasound transducer to noninvasively ablate tissue.
Insightec uses focused ultrasound to treat essential tremor.
Approved around the world for indications such as cancer, chronic pain, and Parkinson’s disease, focused ultrasound is currently in clinical trials for the treatment of conditions including hypertension, tubal pregnancy, and obsessive-compulsive disorder. The technique is also being considered for treatment of Alzheimer’s disease, epilepsy, obesity, and diabetes, among other applications.
Israeli firm Insightec, which already has FDA-approved focused ultrasound devices to treat pain in bone cancer patients and uterine fibroids in women, received approval from the agency last year to trial its ExAblate Neuro for treatment of essential tremor. This year, the company opened centers in China and initiated a $50-million funding round.
Three companies—Illumina; LifeTechnologies, which Thermo Fisher Scientific acquired this year; and Roche—have thus far owned the gene sequencing market. But competition is heating up.
Illumina’s HiSeq X Ten cracked the $1000 genome, opening the floodgates for other next-generation sequencing technologies.
Over the past year, the number of firms competing in the space rose by almost 10, nearly tripling the field, according to Frost & Sullivan. Mergers and acquisitions also mixed things up in 2014.
“In order to gain access to newer technologies, companies like Bio Rad and Roche acquired companies such as Genia and Gnubio, who had promising technology platforms based on nanopore sequencing,” says Divyaa Ravishankar, a senior life sciences industry analyst with Frost & Sullivan.
More than five years ago, Apple sold consumers on mobile applications by telling them no matter what they want to do, “there’s an app for that.” The same couldn’t be said for healthcare providers and patients.
Last July, there were more than 1.5 billion apps in the iTunes and Google Play stores combined. Less than 2% of them—fewer than 28,000—were classified as medical, according to the publication iMedicalApps.
But thanks to FDA’s risk-based regulatory framework, announced in September 2013, and predictions that the market for mobile medical apps could grow to 26-billion users by 2017, more companies are starting to try their hand at mobile medical apps.
Apple’s HealthKit will enable health and fitness apps to share data with each other as well as the company’s Health app.
“2014 was the year of the app,” says Steve Wilcox, founder of Philadelphia design firm Design Science.
Consumer tech giants Apple, Google, and Microsoft grabbed headlines with platforms that enable more health and fitness app development, while several traditional medical device companies launched notable apps as well. One is Dexcom’s Follow, which is used in conjunction with a docking cradle to enable diabetics to share data from their continuous glucose monitors. AliveCor also got FDA clearance for an algorithm to detect atrial fibrillation using its ECG smartphone attachment and app.
As developers become more familiar with FDA regulation, expect to see mobile medical apps jump from simply cool to clinically useful.
<MD+DI> 2014.12 ; Jamie Hartford.