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New Apple Watch to change ECG OTC products How is FDA regulated?

via:博客园     time:2018/9/14 8:32:02     readed:213

Our reporter Lu Shan Shanghai report

Apple's entry into the medical device sector is a bit faster.

On September 13th, the Apple Watch Series 4 was unveiled at Apple's new product launch conference in the fall of 2018. In addition to the screen's 30% increase, the heart rate monitoring function was extended and the first OTC ECG product was upgraded to become the biggest selling point, and it was approved by the US FDA. The GPS version is $399 and the cellular version is $499.

Apple CEO Cook said that Apple Watch is currently the world's number one sales watch. Wearables is one of Apple's fastest-growing product lines, and it's also a high hope for Apple's future market.

In 2015, Apple introduced the first generation of Apple Watch with an optical heart rate sensor that quickly measures heart rate and then iterates year after year. It is still too early to say that Apple has to cut into the medical device field. The ECG ECG monitoring function has actually entered the ranks of digital medical care.

In 2017, the FDA launched the Digital Health Innovation Action Plan and an accompanying software pre-certification pilot program. The FDA affirms that its pilot program will help develop a regulatory model to assess the safety and effectiveness of software technology without compromising patient access to these technologies.

Apple was one of the first nine companies to participate in the pilot. In September 2017, the FDA selected 9 of the more than 100 applicants to participate in the development of the software pre-audit pilot program. In addition to Apple, other companies have technology giant Samsung, there are also wearable device leader Fitbit, as well as traditional pharmaceutical companies, Dasheng, Roche.

FDA Director Scott Gottlieb said, “The initial participants in this new pilot range from small start-ups to large companies developing different risk software products, and we hope to include medical product manufacturers as well as non-traditional software developers. The challenge for the FDA in the past was how to determine how best to standardize these non-traditional medical tools through traditional medical product review methods. We envision and seek to develop a new, pragmatic approach to digital health technology through software pre-test certificates. ”

Wearable device mature

Apple Watch Series 4 has several new features related to health management.

For example, monitoring the heart throughout the day, the wearer can view the heart rate at any time. If it is detected that the wearer has not been active for 10 minutes and the heart rate is below a certain threshold, Apple Watch will give a low heart rate reminder. This may be a symptom of bradycardia, which can have serious consequences if the heart is unable to deliver enough oxygen-rich blood to the body.

With the new acceleration sensor and gyroscope, the Apple Watch can detect if the wearer has fallen. In the event of a similar accident, Apple Watch will issue a serious fall alert, as well as automatic call to emergency calls and sending messages to emergency contacts.

In addition to the Apple Watch with Apple Aura, wearables have entered a broader and professional segmentation period after years of development.

In February of this year, the FDA approved the MIT Media Lab's independent rookie Empatica's artificial intelligence watch Embrace, which is used to monitor a high-risk type of seizure, the first FDA-approved smart watch for neurology. In April, the FDA approved the first medical device IDx-DR to use artificial intelligence to detect retinopathy of diabetic patients. On May 24th, Imagen's OsteoDetect software was also approved by the FDA, which uses machine learning technology to analyze 2D X-rays. The image is judged whether the patient is fractured by recognizing the front and back and side X-ray images of the patient's wrist.

Scott Gottlieb said that in 2017, FDA approved a total of 51 digital health products.

The maturity of digital health technology has driven applications in various fields, such as mobile health applications (Apps) to help consumers manage their health and better control their diet and lifestyle. More and more apps show promise in areas such as diabetes prevention, asthma and addiction recovery. According to industry estimates, by the end of this year, 50% of smartphone and tablet users in the US will download Mobile Health App.

Supervision is also step by step

Just as the medical artificial intelligence has just started, the pace of supervision has gradually kept pace, and the supervision of wearable devices has also followed suit. According to the FDA, more than 165,000 health-related apps were available for Apple or Android smartphones last year.

“The traditional FDA approach to medical devices is not suitable for these new digital medical products. We need to ensure that we have an effective approach to innovative products with continuous updates and upgrades. Scott Gottlieb believes that the potential for digital health is revolutionary, “requires a regulatory framework to accommodate the uniqueness of digital healthcare technology, clinical commitment, unique user interface, and the business cycle of compressing new products. ”

The digital health innovation program launched for this purpose includes new review methods and post-marketing methods to better manage digital medical devices.

“Traditional devices are based on the regulation of the product itself, and the FDA's regulation of AI and digital medical products is divided into two aspects, one is the risk of the product itself, and the other is the risk control of the manufacturer, ie the manufacturer. "The chief medical officer and vice president of regulatory affairs at Boston Science Greater China, and the former US Food and Drug Administration (FDA) equipment center medical officer Zhang Mingdong told the 21st Century Business Herald that the FDA's pre-certification is for manufacturers rather than products.

The pilot program represents a significant change in FDA's regulatory thinking, Scott Gottlieb explained, “The new voluntary pilot program will enable us to consider software developers or digital medical technology developers first, rather than primarily for products (currently for traditional healthcare) Product), develop a customized approach to the technology. The pilot will establish the most appropriate standards to establish a company-based pre-certification program for these new tools. ”

“Difficulties in regulation and approval are related to the characteristics of artificial intelligence and other digital medical devices. "Zhang Mingdong believes that the difficulty lies in the fact that it cannot be like traditional equipment." Medical devices themselves are updated faster, and digital medical device products are updated more quickly. Therefore, supervision of such medical devices cannot continue the traditional regulatory ideas and needs to be adjusted. But the same philosophy is based on risk, that is, regardless of the type of medical device, risk should be considered. ”

There are also many companies in China that are developing products such as wearable devices and medical AI. At the same time, the National Drug Administration NMPA (formerly CFDA) is also actively exploring the regulatory methods.

At present, there are about 1,700 medical devices approved by the FDA, which are classified according to 16 medical professions. The classification determines the degree of risk-based regulatory control. From the first category, the second category to the third category, the risk control increased in turn, and 780 types of low-risk devices, accounting for 45.9%, 93% were exempted from pre-marketing; the second category was moderate risk, about 800 devices. The proportion was 47.1%; the three types of equipment were high risk, accounting for 7.1%. The proportion of Chinese one to three types of equipment is 25%, 48.8%, and 26.2%.

Apple Watch Series 4 will also be approved for related procedures if it enters China. A medical investor told the 21st Century Business Herald that “wearable ECGs are also doing a lot of startups in China, and some have already obtained the second type of certificates. I personally are optimistic about Apple Watch S4, CDE will certainly supervise its medical functions, maybe Apple has got a second type of certificate. ”

The FDA generally does not have formal clinical requirements for Class 2 devices, and CFDA generally requires clinical trials and requires clinical evaluation.

In September 2017, the new edition of the “Medical Devices Classification Catalogue” issued by the State Food and Drug Administration (hereinafter referred to as “New Catalogue”) was implemented on August 1, 2018. As a kind of medical device, wearable medical devices are not much different from general medical devices in the registration and declaration process. Each manufacturer needs to apply according to the catalogue.

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